[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"narcolepsy\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:narcolepsy":29},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,17,0,[8,49,75,99,123,149,178,205,229,258,345,368,390,412,443,463,485],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":30,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":37,"lastUpdatePostDateStruct":38,"startDateStruct":41,"completionDateStruct":43,"leadSponsor":45,"locationsCount":48},"100645025","phase-3-a-phase-3-efficacy-and-safety-study-of-hbs-301-in-participants-with-narcolepsy-100645025",false,"NCT07675135","A Phase 3 Efficacy and Safety Study of HBS-301 in Participants With Narcolepsy","A Phase 3, Randomized, Double-blind, Placebo-Controlled, Efficacy and Safety Study of HBS-301 in Participants With Narcolepsy Followed by an Open-label Extension","Inclusion Criteria:\n\n* Has a current documented diagnosis of NT1 or NT2 per the International Classification of Sleep Disorders, Third Edition (ICSD-3) or the ICSD-3 Text Revision (ICSD-3-TR) within the last 10 years.\n* Has EDS.\n* If taking a permitted chronic concomitant medication or supplement, including nonprohibited antidepressants or wake-promoting agents, must be on a stable dose for at least 3 months prior to Screening and agree to continue at that stable dose for the Double-blind Treatment Period of the study. As needed (PRN) use of any treatment that could affect daytime sleepiness (including but not limited to oxybates, stimulants, modafinil, and armodafinil) is not permitted.\n\nExclusion Criteria:\n\n* Has hypersomnia due to another medical disorder.\n* Has a history of pitolisant use within 5 half-lives prior to Screening.\n* Has a primary diagnosis of psychiatric illness, including depression, that is not well controlled (i.e., symptoms and medications have not been stable for at least 3 months prior to Screening).\n* Has any history of bipolar disorder or psychosis\n* Has acute or chronic liver disease or a history of moderate or severe hepatic impairment.\n* Has a body surface area-corrected estimated glomerular filtration rate (eGFR) \\\u003C60 mL\u002Fmin.\n* Has a known history of long QT syndrome or serious abnormality of the electrocardiogram (ECG).","ALL","18 Years",{"count":19,"type":20},258,"ESTIMATED","INTERVENTIONAL",[23],"PHASE3","This is a Phase 3, multicenter, randomized, double-blind, parallel-group, placebo-controlled clinical study to assess the efficacy and safety of HBS-301 in treating excessive daytime sleepiness (EDS), cataplexy, sleepiness\u002Fwakefulness, and fatigue in adult participants (ages ≥18 years) with narcolepsy.",[26,27,28,29],"EDS","Cataplexy","Fatigue","Narcolepsy",[31,32,33,26,34,35],"pitolisant","HBS-301","narcolepsy","cataplexy","fatigue","RECRUITING","2026-06-25",{"date":39,"type":40},"2026-06-30","ACTUAL",{"date":42,"type":40},"2026-06-04",{"date":44,"type":20},"2027-11",{"name":46,"class":47},"Harmony Biosciences Management, Inc.","INDUSTRY",14,{"id":50,"slug":51,"hasResults":11,"nctId":52,"briefTitle":53,"officialTitle":54,"acronym":4,"eligibilityCriteria":55,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":56,"targetDuration":4,"studyType":21,"phases":58,"briefSummary":59,"conditions":60,"keywords":61,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":66,"lastUpdatePostDateStruct":67,"startDateStruct":69,"completionDateStruct":71,"leadSponsor":73,"locationsCount":4},"100634490","phase-3-a-phase-3-study-to-evaluate-the-efficacy-and-safety-of-samelisant-in-patients-with-narcolepsy-awake-100634490","NCT07540364","A Phase 3 Study to Evaluate the Efficacy and Safety of Samelisant in Patients With Narcolepsy (AWAKE)","A Phase 3, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Efficacy and Safety of Samelisant Compared to Placebo in Patients With Narcolepsy With or Without Cataplexy","Key Inclusion Criteria:\n\n1. Body mass index ranging from 18 to 45 kg\u002Fm2 (both inclusive).\n2. Narcolepsy with or without cataplexy (Narcolepsy Type 1 \\[NT1\\] or Narcolepsy Type 2 \\[NT2\\]) based on the International Classification of Sleep Disorders 3-TR\u002F Diagnostic and Statistical Manual of Mental Disorders (DSM-5-TR) criteria for the diagnosis of narcolepsy.\n3. For NT1 only, current continuing presence of cataplexy as defined by participant report for the last 3 months and have average of ≥4 weekly cataplexy events during the last 2 weeks of the washout period.\n4. At the screening Visit and the Baseline Visit, participants who are not on treatment for EDS must have ESS scores ≥12 (as assessed with a look-back period of 1 week).\n5. A mean MWT time of \\\u003C12 minutes across the first 4 sessions at Baseline.\n6. Willingness to complete the study protocol with full compliance with procedures and sign an informed consent form.\n7. Able to show compliance with sleep diary entries for at least 5 times\u002Fweek in the final 2 weeks of the screening Period (non-compliant participants will not be included).\n\nKey Exclusion Criteria:\n\n1. Median habitual wake-up time after 9 am as assessed by sleep diary, habitual sleep time of \\\u003C6 h and median habitual bedtime past 1 am, as determined by sleep diary entries.\n2. Use of any investigational therapy within the 30-day period (or 5 half-lives, whichever is longer) prior to enrollment.\n3. History of (within past 3 months) or current substance use disorder involving illicit drugs, alcohol, or marijuana, as per DSM-5-TR criteria. Alcohol and\u002For recreational drugs use within 24 hours of study visits is strictly prohibited.\n4. Excessive caffeine (defined as \\>600 mg\u002Fday) use at least 1 week prior to Baseline assessments and during the study.\n5. Nicotine dependence that affects sleep (eg, a participant who routinely awakens at night to smoke).\n6. If receiving stimulants, modafinil, oxybates, pitolisant, solriamfetol, bupropion or other treatments for narcolepsy, and unwilling or unable to complete weaning 2 weeks prior to Baseline visit (Day 1)\n7. Clinically significant ECG abnormalities. Participants are excluded with a screening ECG Fridericia's correction of QT (QTcF) interval ≥450 msec for men and ≥470 msec for women obtained after 5-minute rest in a supine position using a digital ECG.\n8. Concurrent use of hypnotics, tranquilizers, centrally acting H1 receptor antagonists, benzodiazepines, anticonvulsants, or clonidine, tricyclic antidepressants that have H1-antihistamine properties (clomipramine, protriptyline).\n9. Adjunctive pharmacotherapy directed against cataplexy (including but not limited to venlafaxine, fluoxetine, and gamma hydroxybutyrate) is prohibited.\n10. An occupation requiring variable shift work, variable wake times, night shifts, frequent overnight travel or expected overnight travel across \\> 3 time zones during the study which disrupts sleep patterns and working remotely leading to inconsistent sleep duration.",{"count":57,"type":20},240,[23],"The primary objective of this study is to evaluate the effect of Samelisant on excessive daytime sleepiness (EDS) after 12 weeks of treatment. In addition, the study aims to assess its effectiveness in influencing the weekly frequency of cataplexy episodes (sudden bouts of muscle weakness) that occur while the individual remains conscious. Other objectives include examining the impact of Samelisant on attention and alertness, overall quality of life, the spectrum of narcolepsy symptoms, and daily functioning, as well as evaluating its safety profile.",[29],[62,63,64,29,27],"Samelisant","SUVN-G3031","Excessive Daytime Sleepiness","NOT_YET_RECRUITING","2026-06-13",{"date":68,"type":40},"2026-06-16",{"date":70,"type":20},"2026-06-19",{"date":72,"type":20},"2027-12-19",{"name":74,"class":47},"Suven Life Sciences Limited",{"id":76,"slug":77,"hasResults":11,"nctId":78,"briefTitle":79,"officialTitle":80,"acronym":4,"eligibilityCriteria":81,"healthyVolunteers":11,"sex":82,"minAge":4,"maxAge":4,"enrollmentInfo":83,"targetDuration":85,"studyType":86,"phases":4,"briefSummary":87,"conditions":88,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":90,"lastUpdatePostDateStruct":91,"startDateStruct":93,"completionDateStruct":95,"leadSponsor":97,"locationsCount":98},"100480440","wakix-pitolisant-pregnancy-registry-100480440","NCT05536011","WAKIX® (Pitolisant) Pregnancy Registry","WAKIX® (Pitolisant) Pregnancy Registry: An Observational Study of the Safety of Pitolisant Exposure in Pregnant Women and Their Offspring","Inclusion Criteria:\n\n* Pregnant woman of any age\n* Consent to participate\n* Authorization for her HCP(s) to provide data to the registry\n* For participants with a diagnosis of narcolepsy: exposure to at least one dose of pitolisant or one dose of a comparator product, or, unexposed to pitolisant or comparator products at any time during pregnancy (i.e., any pregnant woman with a diagnosis of narcolepsy)\n* For participants without a diagnosis of narcolepsy: exposure to at least one dose of pitolisant or one dose of a comparator product at any time during pregnancy\n\nExclusion Criterion:\n\n• Occurrence of pregnancy outcome prior to first contact with the Registry Coordination Center (RCC) (i.e., retrospectively enrolled)","FEMALE",{"count":84,"type":20},1329,"21 Months","OBSERVATIONAL","The WAKIX (pitolisant) Pregnancy Registry is a US-based, prospective, observational cohort study designed to evaluate the association between pitolisant exposure during pregnancy and subsequent maternal, fetal, and infant outcomes.",[89,29],"Pregnancy Related","2026-06-10",{"date":92,"type":40},"2026-06-12",{"date":94,"type":40},"2021-08-24",{"date":96,"type":20},"2030-06-30",{"name":46,"class":47},1,{"id":100,"slug":101,"hasResults":11,"nctId":102,"briefTitle":103,"officialTitle":104,"acronym":4,"eligibilityCriteria":105,"healthyVolunteers":106,"sex":16,"minAge":17,"maxAge":107,"enrollmentInfo":108,"targetDuration":4,"studyType":21,"phases":110,"briefSummary":112,"conditions":113,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":114,"lastUpdatePostDateStruct":115,"startDateStruct":116,"completionDateStruct":118,"leadSponsor":120,"locationsCount":122},"100643625","phase-1-a-trial-to-test-the-safety-and-tolerability-of-lu-ah69593-in-adults-that-are-healthy-or-have-narcolepsy-100643625","NCT07613710","A Trial to Test the Safety and Tolerability of Lu AH69593 in Adults That Are Healthy or Have Narcolepsy","Interventional, Randomized, Double-blind, Sequential-group, Placebo-controlled, Single- and Multiple-ascending-dose Trial Investigating Safety, Tolerability, and Pharmacokinetics of Lu AH69593 in Healthy Participants, Including Open-label Cohorts to Explore Pharmacodynamic Properties in Participants With Narcolepsy, and Food Effect in Healthy Participants","Key Inclusion Criteria:\n\nFor all participants in any trial Part (A, B, C and D):\n\n* The participant has a resting supine pulse ≥45 and ≤100 beats per minute (bpm) at the Screening Visit and at the Baseline Visit.\n\nSpecifically for participants in trial Part A, B, and D:\n\n* The participant has a body mass index (BMI) ≥18.5 and ≤30 kilograms (kg)\u002Fsquare meter (m\\^2) at the Screening Visit.\n* The participant has a normal circadian rhythm, defined as a person who usually wakes up between 6:00 and 9:00 a.m. and goes to sleep between 9:00 p.m. and midnight.\n* The participant is ≥18 and ≤55 years of age at the Screening Visit.\n\nSpecifically for participants in trial Part C:\n\n* The participant has a BMI ≥18.5 and ≤35 kg\u002Fm\\^2 at the Screening Visit.\n* The participant has NT1, diagnosed according to International Classification of Sleep Disorders, 3rd edition criteria, with a history of disease diagnosis \\>3 months prior to the Screening Visit.\n* The participant is ≥18 and ≤64 years of age at the Screening Visit.\n\nKey Exclusion Criteria:\n\nFor all participants in any trial Part (A, B, C and D):\n\n* The participant has previously been enrolled in this trial.\n* The participant has previously been dosed with Lu AH69593.\n* The participant has participated in a clinical trial \\\u003C30 days prior to the Screening Visit.\n* The participant is pregnant, breastfeeding, intends to become pregnant, or is of childbearing potential and not willing to use adequate contraceptive methods.\n* The participant has a history of cancer, other than basal cell or Stage 1 squamous cell carcinoma of the skin or adequately treated cervical intraepithelial neoplasia, that has not been in remission for \\>5 years prior to the first dose of investigational medicinal product (IMP).\n* The participant has worked shifts, including night duty, or has travelled across \\>3 time zones \\\u003C2 weeks prior to the first dose of IMP.\n* The participant trains\u002Fexercises intensively, for example, for a marathon or triathlon, or at a competitive level.\n\nSpecifically for participants in trial Part A, B and D:\n\n* The participant has had a clinically significant illness from which he\u002Fshe recovered \\\u003C4 weeks prior to the first dose of IMP.\n\nSpecifically for Participants in trial Part B and C:\n\n* The participant is at significant risk of suicide based on medical history, mental status, investigator judgement, or the C-SSRS answer of 'yes' to suicidal ideation question 4 or 5 or 'yes' to suicidal behaviour, within the last 6 months on the C-SSRS at the Screening Visit or 'Since last visit' at the Baseline Visit Day -1.\n\nSpecifically for participants in trial Part C:\n\n* The participant has any other disorder for which the treatment takes priority over treatment of narcolepsy or is likely to interfere with trial treatment or impair treatment compliance.\n* The participant has a current medical disorder, other than NT1, associated with excessive daytime sleepiness (EDS).\n\nNote: Other protocol-defined inclusion and exclusion criteria may apply.",true,"64 Years",{"count":109,"type":20},104,[111],"PHASE1","The purpose of the trial is to determine if Lu AH69593 is safe and well tolerated. The trial will also look at how the body processes Lu AH69593 with and without food.",[29],"2026-06-08",{"date":90,"type":40},{"date":117,"type":40},"2025-06-13",{"date":119,"type":20},"2026-12-18",{"name":121,"class":47},"H. Lundbeck A\u002FS",2,{"id":124,"slug":125,"hasResults":11,"nctId":126,"briefTitle":127,"officialTitle":127,"acronym":128,"eligibilityCriteria":129,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":130,"targetDuration":4,"studyType":21,"phases":132,"briefSummary":134,"conditions":135,"keywords":137,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":139,"lastUpdatePostDateStruct":140,"startDateStruct":142,"completionDateStruct":144,"leadSponsor":146,"locationsCount":98},"100498716","evaluation-of-social-cognition-in-patient-with-type-1-or-type-2-narcolepsy-versus-patients-with-idiopathic-hypersomnia-100498716","NCT05773872","Evaluation of Social Cognition in Patient With Type 1 or Type 2 Narcolepsy Versus Patients With Idiopathic Hypersomnia","COGNAR","Inclusion Criteria:\n\n* adult patients (\\>\u002F= 18years old)\n* diagnosis of type 1 or type 2 narcolepsy or idiopathic hypersomnia\n* non opposition\n\nExclusion Criteria:\n\n* comorbid psychiatric or neurologic disease\n* patient under 18 years old\n* patient under guardianship, curators or deprived of liberty, refusal of the patient",{"count":131,"type":20},75,[133],"NA","Narcolepsy is a chronic disabling neurologic disorder mainly characterised by excessive daytime sleepiness. Type 1 narcolepsy is associated with a deficit of hypocretin in the cerebrospinal fluid responsible for the cataplexy symptom while type 2 shows a normal hypocretin level and no cataplexy. While the development of narcolepsy is independent of parental social level, narcolepsy has a significant influence on educational level, grading, social outcome, and welfare consequences. Several studies assessed global cognition efficiency, mood, and attention in narcoleptic patients but only a few specifically measured social cognition and mostly without a control group.\n\nIn a population of narcoleptics children, a severe impairment in social cognition is described for 20% of the group, contrary to 2 % for the control group. The literature also depicts some impairments in decision making, somatic and cognitive emotions responses but the emotion recognition seems to be preserved.\n\nA better understanding of the social and cognitive aspects of narcolepsy could lead to a better treatment of the disease in its entirety, including if relevant specific cognitive behavioural therapy.\n\nThe protocol consists in a psychometric evaluation including several questionnaires in order to assess social cognition. It will be proposed to patients with type 1 or type 2 narcolepsy and patients with idiopathic hypersomnia.",[29,136],"Social Cognition",[29,138],"social cognition","2026-05-28",{"date":141,"type":40},"2026-06-01",{"date":143,"type":40},"2022-11-18",{"date":145,"type":20},"2027-05",{"name":147,"class":148},"Centre Hospitalier Universitaire, Amiens","OTHER",{"id":150,"slug":151,"hasResults":11,"nctId":152,"briefTitle":153,"officialTitle":154,"acronym":155,"eligibilityCriteria":156,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":157,"enrollmentInfo":158,"targetDuration":4,"studyType":21,"phases":160,"briefSummary":161,"conditions":162,"keywords":164,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":171,"lastUpdatePostDateStruct":172,"startDateStruct":173,"completionDateStruct":174,"leadSponsor":176,"locationsCount":98},"100640164","phase-3-a-study-evaluating-the-efficacy-and-safety-of-xywav-expanded-dosing-vs-placebo-in-participants-with-narcolepsy-or-ih-100640164","NCT07625280","A Study Evaluating the Efficacy and Safety of Xywav Expanded Dosing vs Placebo in Participants With Narcolepsy or IH","A Phase 3, Multicenter, Double-blind, Placebo-controlled, Randomized-withdrawal Study to Evaluate the Efficacy and Safety of Expanded Dosing Regimens for Xywav in Adult Participants With Narcolepsy or Idiopathic Hypersomnia","XYRISE","Inclusion Criteria:\n\n1. Has a primary diagnosis of IH or narcolepsy Type 1 or Type 2 (NT1 or NT2)\n2. If not currently treated with oxybate, has clinically significant symptoms of excessive daytime sleepiness (EDS) with an Epworth Sleepiness Scale (ESS) score \\> 11 at screening.\n3. If currently treated with oxybate, must have documented improvement of EDS with oxybate treatment per the investigator's clinical judgement.\n4. If currently treated with oxybate, has been taking the same stable dosing regimen at a total nightly dosage of 3 g to 9 g (inclusive) for at least 2 months at screening.\n5. If previously treated with (and not currently taking) oxybate, must have been off oxybate treatment for at least 2 weeks prior to screening. Must not have previously discontinued oxybate due to reasons related to intolerability, safety, or lack of efficacy.\n6. If currently treated with anticataplectics (NT1 only) and\u002For alerting agents, has been taking the same dosage for at least 1 month prior to screening and has no current plans to adjust the dosage during the study period.\n7. If currently treated with nicotine replacement therapy, has been taking the same dosage for at least 1 month prior to screening and has no current plans to adjust the dosage during the study period.\n8. Adequate contraceptive precautions\n\nExclusion criteria:\n\n1. Shows evidence of a previous untreated or inadequately treated sleep disorder considered by the investigator to negatively impact the conduct of the study, including sleep-disordered breathing, parasomnias, circadian rhythm sleep disorders, or restless legs syndrome determined by a previous sleep-laboratory diagnosis or interview utilizing modules of the Diagnostic Interview for Sleep Patterns and Disorders.\n2. Has succinic semi-aldehyde dehydrogenase deficiency by medical history.\n3. Has uncontrolled hypothyroidism as determined by central clinical laboratory test results.\n4. Has a current seizure disorder.\n5. Has a history of head trauma associated with loss of consciousness in the past 5 years\n6. Has a history or presence of bipolar disorder, bipolar-related disorders, schizophrenia, schizophrenia spectrum disorders, or other psychotic disorders\n7. Has a history or presence of any unstable or clinically significant medical condition, behavioral or psychiatric disorder, or history or presence of another neurologic disorder or surgical history that might affect the participant's safety and\u002For interfere with the conduct of the study, in the opinion of the investigator.\n8. Has any other significant disease or disorder that, in the opinion of the investigator, may either put the participant, other participants, or study staff at risk because of participation in the study, may influence the result of the study, or may affect the participant's safety or ability to take part in the study.\n9. Any past or current medical conditions or experience that, in the investigator's clinical judgment, would preclude treatment with a once-nightly dose \\> 6 g up to 7.5 g dose or twice-nightly regimen with a total nightly dosage \\> 9 g up to 12 g (divided into 2 doses).\n10. Has any severe drug allergy or a history of allergic or severe adverse reactions or intolerance to Xyrem, Xywav, Gamma-hydroxybutyrate (GHB), or any components of the dosage forms.\n11. Has recently taken, is taking, or plans to take any of the following:\n\n    1. A substance or medication contraindicated with Xywav use\n    2. A medication with a known drug-drug interaction with Xywav\n    3. Medications known to have clinically significant CNS sedating effects:\n    4. Other medications, natural health products, or substances from which the participant experiences clinically significant sedation\n12. Has recently taken, is taking, or plans to take an Orexin 2 receptor (OX2R) agonist during the study.\n13. Has tobacco-use disorder or uses vaping products that impact sleep\n14. Has excessive caffeine consumption that may impact sleep\n15. Has clinically significant abnormal laboratory values\n16. Has an occupation that requires nighttime or variable shift work\n17. Has plans for travel across more than 3 time zones during the study","75 Years",{"count":159,"type":20},108,[23],"The purpose of this study is to evaluate the efficacy and safety of expanded Xywav dosing regimens in adult participants with narcolepsy or idiopathic hypersomnia (IH).",[29,163],"Idiopathic Hypersomnia",[165,166,167,168,169,170],"Xywav","Narcolepsy Type 1","NT1","Narcolepsy Type 2","NT2","IH","2026-05-27",{"date":42,"type":40},{"date":39,"type":20},{"date":175,"type":20},"2028-01-06",{"name":177,"class":47},"Jazz Pharmaceuticals",{"id":179,"slug":180,"hasResults":11,"nctId":181,"briefTitle":182,"officialTitle":183,"acronym":4,"eligibilityCriteria":184,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":185,"targetDuration":4,"studyType":21,"phases":187,"briefSummary":189,"conditions":190,"keywords":191,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":195,"lastUpdatePostDateStruct":196,"startDateStruct":198,"completionDateStruct":200,"leadSponsor":202,"locationsCount":204},"100630868","phase-2-a-study-to-evaluate-the-efficacy-and-safety-of-e2086-in-adults-with-narcolepsy-100630868","NCT07493265","A Study to Evaluate the Efficacy and Safety of E2086 in Adults With Narcolepsy","A Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate the Efficacy and Safety of E2086 in Adults With Narcolepsy","Inclusion Criteria:\n\nParticipants must meet all of the following criteria to be included in this study:\n\n1. Male or female, age greater than or equal to (\\>=) 18 years (or as regionally appropriate) at the time of informed consent\n2. NT1 Cohort: Must fulfill Inclusion Criteria 2a and 2b\n\n   1. Diagnosis of NT1 within the last 10 years of screening, as confirmed by at least one of the following:\n\n      * Polysomnography (PSG) and Multiple Sleep Latency Test (MSLT) results, and clinical history, consistent with the 2023 International Classification of Sleep Disorders, 3rd edition, text revision (ICSD-3-TR) criteria for NT1\n      * Cerebrospinal fluid orexin-A\u002Fhypocretin-1 concentration less than or equal to (\\\u003C=) 110 picograms per milliliter (pg\u002FmL)\n   2. At least 4 or more episodes of cataplexy\u002Fweek as averaged over 2 weeks minimum and confirmed by the cataplexy portion of the Diary If PSG or MSLT results are not available within the last 10 years of screening to fulfill Criterion 2a then screening assessment results for PSG or MSLT can be used instead\n3. NT2 Cohort: Diagnosis of NT2 within the last 10 years of screening, as confirmed by PSG and MSLT results, and clinical history, consistent with the 2023 ICSD-3-TR criteria for NT2 If PSG or MSLT results are not available within the last 10 years of screening to fulfill Criterion 3 then screening assessment results for PSG or MSLT can be used instead\n4. ESS score \\>=10\n5. Reports regular bedtime, defined as the time that the participant attempts to sleep, between 22:00 and 01:00 (based on data from the screening Diary)\n6. Reports regular waketime, defined at the time the participant gets out of bed for the day, between 05:00 and 10:00 (based on data from the screening Diary)\n7. Reports being in bed between 7 and 9 hours per night (based on data from the sleep portion of the Diary)\n8. Compliance rate \\>=80 percentage (%) for completion of the Diary during screening\n9. Body mass index (BMI) \\>=18 to less than (\\\u003C) 35 kilograms per square meter (kg\u002Fm\\^2) at Screening\n\nExclusion Criteria:\n\n1. Females who are breastfeeding or pregnant at Screening or Baseline (as documented by a positive beta-human chorionic gonadotropin \\[ß-hCG\\] (or human chorionic gonadotropin \\[hCG\\]) test with a minimum sensitivity of 25 international units per liter (IU\u002FL) or equivalent units of ß-hCG \\[or hCG\\]). A separate baseline assessment is required if a negative screening pregnancy test was obtained more than 72 hours before the first dose of study drug\n2. Females of childbearing potential who:\n\n   * Within 28 days before study entry, did not use a highly effective method of contraception, which includes any of the following:\n\n     1. total abstinence (if it is their preferred and usual lifestyle)\n     2. an intrauterine device or intrauterine hormone-releasing system (IUS)\n     3. a contraceptive implant\n     4. Combined estrogen and progestogen-containing hormonal contraception (oral, intravaginal, transdermal) or progestogen-only hormonal contraception associated with inhibition of ovulation, such as desogestrel (oral, injectable). Participants using hormonal contraceptives must be on a stable dose of the same contraceptive product for at least 28 days before dosing, throughout the study and for at least 28 days following study drug discontinuation\n     5. have a vasectomized partner with confirmed azoospermia\n   * Do not agree to use a highly effective method of contraception (as described above) throughout the entire study period and for 28 days after study drug discontinuation.\n\n   Participants on an oral contraceptive must use an additional study method throughout the study and for 28 days after study drug discontinuation. For sites outside of Europe, it is permissible that if a highly effective method of contraception is not appropriate or acceptable to the participant, then the participant must agree to use a medically acceptable method of contraception, that is, double-barrier methods of contraception such as latex or synthetic condom plus diaphragm or cervical\u002Fvault cap with spermicide.\n\n   NOTE: All females will be considered to be of childbearing potential unless they are postmenopausal (amenorrheic for at least 12 consecutive months, in the appropriate age group, and without other known or suspected cause) or have been sterilized surgically (that is, bilateral tubal ligation, total hysterectomy, or bilateral oophorectomy, all with surgery at least 1 month before dosing).\n3. Clinically significant illness that requires medical treatment within 8 weeks of dosing or a clinically significant infection that requires medical treatment within 4 weeks of dosing\n4. Evidence of disease that may influence the outcome of the study within 4 weeks before dosing (for example, psychiatric disorders and disorders of the gastrointestinal tract, liver, kidney, respiratory system, endocrine system, hematological system, neurological system, or cardiovascular system)\n5. Any history of surgery that may affect PK profiles of E2086 (for example, hepatectomy, nephrectomy, digestive organ resection) or who have a congenital abnormality in metabolism at Screening\n6. Any clinically abnormal symptom or organ impairment found by medical history at Screening, including severe renal impairment (estimated glomerular filtration rate \\[eGFR\\] \\\u003C30 milliliters per minute (mL\u002Fmin), and physical examinations, vital signs, ECG findings, or laboratory test results that require medical treatment at Screening or Baseline\n7. A prolonged QTc interval calculated using Fridericia's formula (QTcF) greater than 450 milliseconds (ms) according to central reading at Screening or Baseline. If the QTcF machine read is greater than 450 ms on the first single 12-lead ECG, 2 additional 12-lead ECGs will be performed 1 minute apart and the mean of the 3 QTcF values will be calculated\n8. Persistent systolic BP greater than (\\>) 130 or \\\u003C100 millimeters of mercury (mmHg) or diastolic BP \\>85 or \\\u003C50 mmHg at Screening (based on BP measured on at least 3 occasions over 2 weeks), or at Baseline. If outside of these limits at Screening or Baseline, BP should be repeated twice with at least 5 minutes between measurements\n9. Persistent HR less than 50 beats\u002Fmin or more than 100 beats\u002Fmin at Screening (based on HR measured on at least 3 occasions over 2 weeks), or at Baseline. If outside of these limits at Screening or Baseline, HR should be repeated twice with at least 5 minutes between measurements\n10. Any lifetime history of suicidal behavior as indicated by the C-SSRS\n11. Current unstable psychiatric disorder, current active major depressive episode or an active major depressive episode in the past 6 months\n12. Any suicidal ideation with intent with or without a plan at Screening or within 6 months of Screening (that is, answering \"Yes\" to questions 4 or 5 on the Suicidal Ideation section of the C-SSRS)\n13. Psychotic disorder(s) or unstable recurrent affective disorder(s) evident by use of antipsychotics within 2 years before Screening\n14. Hypersensitivity to the study drug or any of the excipients\n15. Intake of herbal preparations containing St. John's Wort within 5x the half-life before dosing\n16. Any history of or concomitant medical condition that in the opinion of the investigator(s) would compromise the participant's ability to safely complete the study\n17. Planned surgery that requires general, spinal, or epidural anesthesia that would take place during the study. Planned surgery which requires only local anesthesia and that can be undertaken as a day case without inpatient stay postoperatively need not result in exclusion if in the opinion of the investigator this operation does not interfere with study procedures and participant safety\n18. Known to be human immunodeficiency virus (HIV) positive\n19. Acute Epstein Barr virus (EBV) infection with a positive EBV Viral Capsid Antigen Antibody (VCA) IgM at Baseline\n20. Known to be hepatitis B virus (HBV)-positive with a detectable HBV (for example, hepatitis B surface antigen \\[HBsAg\\] reactive) within 6 months before the 1st dose of study drug, or hepatitis C virus (HCV) positive with a detectable (for example, HCV ribonucleic acid (RNA) \\[qualitative\\]) viral load. Note: Participants who are HCV positive due to prior resolved disease can be enrolled, only if a confirmatory negative HCV RNA test is obtained and the participant has completed active treatment\n21. Initiation of statin therapy, or a change to a different statin, or an increase in the dose of a statin within the 6 months before the planned start of study drug\n22. History of formally diagnosed moderate to severe obstructive sleep apnea (OSA)\n23. Current use of continuous positive airway pressure (CPAP), hypoglossal nerve stimulator, oral device, or other therapy for the treatment of OSA\n24. Symptomatic restless legs syndrome\n25. Apnea-hypopnea index \\>=15 on Screening PSG\n26. Use of anticataplectic medications (including but not limited to antidepressants) within 5× the half-life before Screening\n27. Use of psychostimulant medications, prescription and over-the-counter (OTC), within 5× the half-life before Screening until after the Follow-Up Visit. Examples of prohibited medications include OTC stimulants (for example, pseudoephedrine), methylphenidate, amphetamines, modafinil, armodafinil, sodium oxybate, pitolisant, solriamfetol, and pemoline\n28. Use of sleep promoting or sedating medications, prescription and OTC, within 5x the half-life before Screening until after the Follow-Up Visit. Examples of prohibited medication include OTC sleep aids, trazodone, hypnotics, benzodiazepines, barbiturates,cannabinoids, melatonin, melatonin receptor agonists, dual orexin receptor antagonists, and opioids\n29. Inability to discontinue use of strong (such as antifungal itraconazole and antibiotic clarithromycin) and moderate (such as antifungal fluconazole) Cytochrome P450 3A (CYP) 3A inhibitors within 5x the half-life before dosing until after the Follow-Up Visit\n30. Inability to discontinue use of CYP3A inducers (such as antibiotic rifampicin and anti-convulsant phenytoin) within 5x the half-life before dosing until after the Follow-Up Visit\n31. History of drug or alcohol dependency or abuse within 2 years before Screening, or those who have a positive urine drug test or breath (or urine) alcohol test at Screening or Baseline\n32. Does not agree to abstain from use of recreational drugs during the study\n33. Currently enrolled in another clinical study or used any investigational drug or device within 28 days or 5x the half-life, whichever is longer, preceding informed consent\n34. Receipt of blood products within 4 weeks of dosing, donation of blood within 8 weeks of dosing, or donation of plasma within 1 week of dosing\n35. Past participation in a study of an orexin agonist if discontinuation of orexin agonist use was related to an adverse drug reaction or inefficacy",{"count":186,"type":20},64,[188],"PHASE2","The primary purpose of this study is to evaluate the optimal doses of E2086 compared to placebo in participants with narcolepsy for reduction of excessive daytime sleepiness (EDS) as assessed by Mean Sleep Latency (MSL) (measured from the first 4 maintenance of wakefulness tests \\[MWTs\\]).",[29],[192,193,194],"Narcolepsy type 1 (NT1)","Narcolepsy type 2 (NT2)","E2086","2026-05-11",{"date":197,"type":40},"2026-05-14",{"date":199,"type":40},"2026-03-26",{"date":201,"type":20},"2027-03-01",{"name":203,"class":47},"Eisai Inc.",57,{"id":206,"slug":207,"hasResults":11,"nctId":208,"briefTitle":209,"officialTitle":209,"acronym":4,"eligibilityCriteria":210,"healthyVolunteers":106,"sex":16,"minAge":211,"maxAge":212,"enrollmentInfo":213,"targetDuration":4,"studyType":86,"phases":4,"briefSummary":215,"conditions":216,"keywords":217,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":220,"lastUpdatePostDateStruct":221,"startDateStruct":223,"completionDateStruct":225,"leadSponsor":227,"locationsCount":98},"100537547","proteomics-and-metabolomics-of-body-fluid-in-patients-with-narcolepsy-100537547","NCT06279247","Proteomics and Metabolomics of Body Fluid in Patients With Narcolepsy","Inclusion Criteria\n\n* All patients met the diagnostic criteria of the International Classification of Sleep Disorders, Third edition (ICSD-3).\n\nExclusion Criteria\n\n* primary hypersomnia or hypersomnia due to shift work, sleep deprivation and other sleep rhythm disturbances;\n* excessive sleep due to drug abuse;\n* suffering from Parkinson's disease, Alzheimer's disease and other nervous system diseases and mental diseases;\n* complicated with heart, lung, liver, kidney, blood endocrine system and other basic diseases, or acute chronic infection in a short period of time;\n* Use of sedatives, hypnotics, antidepressants, lithium and dopamine receptor antagonists for two weeks before examination;\n* patients who cannot cooperate with PSG and MSLT due to various factors.","5 Years","100 Years",{"count":214,"type":20},60,"Narcolepsy (NRL) is a rare chronic central nervous system dysfunction disease, which is more common in children and adolescents, and less common in adults. Its typical clinical features include excessive daytime sleep, paroxysmal cataplexy, sleep paralysis and sleep hallucination. In addition to the above typical manifestations, patients with narcolepsy can also manifest as hyperappetite, weight gain, multiple dreams, sleep fragmentation, anxiety and depression and other emotional disorders. In particular, in narcolepsy type 1 with cataplexy, cataplexy episodes can be confused with falls caused by seizures, transient ischemic attacks or neuromuscular disorders, or even mental conversion disorders. Due to its diverse clinical symptoms, it is easy to be missed and misdiagnosed.\n\nAt present, the pathogenesis of narcolepsy is still unclear, and its pathogenesis may be related to immune, genetic, environmental, infection, central nervous system degeneration and other factors. This study aims to investigate the changes of body fluid proteomics and metabolomics in patients with narcolepsy, and to provide an important basis for the pathogenesis of narcolepsy.",[29],[29,218,219],"metabonomics","proteomics","2026-03-22",{"date":222,"type":40},"2026-03-24",{"date":224,"type":40},"2022-09-01",{"date":226,"type":20},"2027-08-26",{"name":228,"class":148},"Qilu Hospital of Shandong University",{"id":230,"slug":231,"hasResults":11,"nctId":232,"briefTitle":233,"officialTitle":234,"acronym":235,"eligibilityCriteria":236,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":237,"targetDuration":4,"studyType":21,"phases":239,"briefSummary":240,"conditions":241,"keywords":246,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":249,"lastUpdatePostDateStruct":250,"startDateStruct":252,"completionDateStruct":254,"leadSponsor":256,"locationsCount":98},"100545584","decreasing-nightmares-in-adults-with-narcolepsy-100545584","NCT06383806","Decreasing Nightmares in Adults With Narcolepsy","Imagery Rehearsal Therapy for the Treatment of Nightmares in Narcolepsy: A Pilot Randomized Controlled Trial","DAWN","PARTICIPANTS WITH NARCOLEPSY\u002FNIGHTMARES\n\nInclusion Criteria:\n\n* Diagnosis of narcolepsy type 1 or narcolepsy type 2\n* Nightmare frequency of ≥1 times per week\n* Age 18 or older\n* Able to speak, read, and write in English\n* Live in the United States\n* Sleep and psychiatric medications stable for ≥ 1 month and willing to keep medications stable for the duration of the study\n\nExclusion Criteria:\n\n* Currently engaged in trauma- or sleep-related psychotherapy\n* Previous behavioral treatment for nightmares\n* Medical, psychiatric, or cognitive condition which would interfere with ability to engage in the treatment\n* Untreated moderate-severe sleep apnea\n\nPARTICIPANTS WHO ARE PARTNERS OF SOMEONE WITH NARCOLEPSY\n\nInclusion Criteria:\n\n* Live with a romantic partner who meets the above criteria and has agreed to participate in the study\n* Age 18 or older\n* Able to speak, read, and write in English\n* Live in the United States",{"count":238,"type":20},80,[133],"The purpose of this clinical trial is learn whether a behavioral (non-medication) treatment can reduce nightmares in adults with narcolepsy. All participants will receive the treatment and will complete three assessments. Half of the participants will receive the treatment after the first assessment, and half will receive it after the second assessment. Romantic partners of participants with narcolepsy will also be eligible to enroll in the study. Partners will complete three assessments but will not participate in the treatment.",[29,166,242,243,244,245],"Narcolepsy With Cataplexy","Narcolepsy Without Cataplexy","Nightmare","Nightmare Disorder With Associated Other Sleep Disorder",[247,248],"Imagery Rehearsal Therapy","Cognitive Behavioral Therapy for Nightmares","2026-03-09",{"date":251,"type":40},"2026-03-10",{"date":253,"type":20},"2026-04-01",{"date":255,"type":20},"2027-09",{"name":257,"class":148},"University of Utah",{"id":259,"slug":260,"hasResults":11,"nctId":261,"briefTitle":262,"officialTitle":263,"acronym":4,"eligibilityCriteria":264,"healthyVolunteers":106,"sex":16,"minAge":265,"maxAge":4,"enrollmentInfo":266,"targetDuration":268,"studyType":86,"phases":4,"briefSummary":269,"conditions":270,"keywords":314,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":336,"lastUpdatePostDateStruct":337,"startDateStruct":339,"completionDateStruct":341,"leadSponsor":343,"locationsCount":98},"100424417","unhide-project-a-digital-health-platform-to-collect-lifestyle-data-for-brain-inflammation-research-100424417","NCT04806620","Unhide® Project: A Digital Health Platform to Collect Lifestyle Data for Brain Inflammation Research","Unhide® Project Also Known as The Unhide® Solve Together Unified Platform","Participants may be either self-diagnosed, or diagnosed by a physician with the following conditions:\n\n* Infection-associated chronic conditions such as Long COVID, chronic Lyme, myalgic encephalomyelitis (ME\u002FCFS), and post-acute neuropsychiatric syndrome (PANS\u002FPANDAS).\n* Neuroimmune, developmental, autonomic, and neurological conditions like migraines, dysautonomia, POTS, multiple sclerosis, and autism spectrum disorder.\n* Autoimmune diseases such as Lupus, Sjogren's Disease, rheumatoid arthritis, myasthenia gravis, ankylosing spondylitis, and related autoimmune conditions.\n\nInflammatory gastrointestinal conditions such as Crohn's Disease, Celiac Disease, and ulcerative colitis.\n\n* Behavioral and mood disorders such as anxiety, depression, bipolar disorder, PTSD, eating disorders, OCD, and other related conditions.\n* \"Healthy\" people (without brain inflammation), including unaffected individuals, unaffected individuals in the same household, and unaffected individuals who are married to relatives and family members.\n* Have consistent internet access and a cell phone, tablet, or PC since this is an online or app-based platform that requires entering data and completing surveys.\n* Currently live in the United States\n* Be able to participate in English (stay tuned for updates about the Spanish language version)\n* Be willing to share symptom and health data through the platform","2 Years",{"count":267,"type":20},10000,"10 Years","The unhide® Project is a non-interventional, longitudinal research study designed to establish a secure data repository of demographic, health, and lifestyle information from individuals with brain inflammation and related neuroinflammatory conditions. Participants in the United States aged 2 years and older will provide self-reported health data, biometrics, and symptom diaries through the MyDataHelps™ app (branded as unhide® for this study). The goal is to create comprehensive longitudinal profiles to facilitate research into disease subtypes, causes, diagnostics, and potential treatments, as well as to identify potential participants for future optional studies. \"Healthy\" individuals without brain inflammation are also eligible to participate.\n\nThe digital health research platform used in this study was originally developed and designed by Solve M.E and was called SolveTogether. The Brain Inflammation Collaborative (BIC) expanded upon Solve M.E.'s work to include related diagnoses, pediatric participants, enhance symptom tracking, and more. BIC and Solve M.E. combined Solve Together and unhide®, to create The unhide® Solve Together Unified Platform in 2025.",[271,272,273,274,275,276,277,278,279,280,281,282,283,284,285,286,287,288,289,290,291,292,293,294,295,296,297,298,29,299,300,301,302,303,304,305,306,307,308,309,310,311,312,313],"Post-Acute COVID-19 Syndrome","ME\u002FCFS","Rheumatic Arthritis","Juvenile Rheumatoid Arthritis (JRA)","Psoriatic Arthritis (PsA)","Ankylosing Spondylitis (AS)","Autoimmune Encephalitis","Celiac Disease","Celiac Disease in Children","Chronic Lyme Disease","Post-treatment Lyme Disease Syndrome","Crohn's Disease","Dysautonomia","Anorexia Nervosa","Bulimia Nervosa","ARFID","Avoidant \u002F Restrictive Food Intake Disorder","Ehlers Danlos Syndrome","Endometriosis","Fibromyalgia (FM)","Long COVID","Lupus","Migraines","Mast Cell Activation Syndrome","Multiple Sclerosis","Myalgic Encephalomyelitis (ME)","Myasthenia Gravis, Generalized","Myasthenia Gravis in Children","Obsessive Compulsive Disorder (OCD)","PANDAS","Pediatric Acute-onset Neuropsychiatric Syndrome (PANS)","POTS - Postural Orthostatic Tachycardia Syndrome","General Anxiety Disorder, Social Anxiety Disorder","PTSD - Post Traumatic Stress Disorder","Psoriasis","Traumatic Brain Injury","Tourette's Syndrome","Inflammatory Bowel Disease (IBD)","Autoimmune Diseases","Neurological Diseases or Conditions","Psychiatric Disorder","Sjogren's Syndrome","Ulcerative Colitis and Crohn's Disease",[291,315,316,317,318,319,320,321,322,323,272,324,325,326,327,328,293,329,330,331,332,28,333,334,335],"Myalgic Encephalomyelitis","Chronic Fatigue Syndrome","Longitudinal Natural History Study","Observational","Neuroinflammatory Disease","Brain inflammation","Neuroinflammatory disorders","PANS\u002FPANDAS","Autoimmune encephalitis","Dysautonomia \u002F POTS","Multiple sclerosis","Autoimmune disease","Inflammatory bowel disease (Crohn's, ulcerative colitis)","Celiac disease","Mood disorders (anxiety, depression, bipolar, PTSD, OCD)","Mobile health app","Patient registry","Wearable devices","Post-exertional malaise","Brain Fog","Mental health","2026-01-20",{"date":338,"type":40},"2026-01-22",{"date":340,"type":40},"2023-07-05",{"date":342,"type":20},"2030-12-31",{"name":344,"class":148},"Brain Inflammation Collaborative",{"id":346,"slug":347,"hasResults":11,"nctId":348,"briefTitle":349,"officialTitle":349,"acronym":4,"eligibilityCriteria":350,"healthyVolunteers":11,"sex":16,"minAge":351,"maxAge":157,"enrollmentInfo":352,"targetDuration":4,"studyType":21,"phases":354,"briefSummary":355,"conditions":356,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":359,"lastUpdatePostDateStruct":360,"startDateStruct":362,"completionDateStruct":364,"leadSponsor":366,"locationsCount":98},"100577360","the-impact-of-light-electrical-and-magnetic-neuroregulation-interventions-on-sleep-wake-disorders-100577360","NCT06797284","The Impact of Light, Electrical, and Magnetic Neuroregulation Interventions on Sleep-wake Disorders","Inclusion Criteria:\n\n\\- Patients with insomnia, narcolepsy,and RBD that have been clearly diagnosed by specialists should sign the informed consent form.\n\nExclusion Criteria:\n\n1. Patients with major neurological diseases such as multi-infarct dementia, Huntington\\'s disease, normal pressure hydrocephalus, brain tumors, progressive supranuclear palsy, epilepsy, subdural hematoma, multiple sclerosis, or those who have sustained neurological dysfunction or known structural brain abnormalities after significant head trauma are excluded.\n2. A history of major depressive disorder or bipolar disorder within the past year, as defined in DSM-IV criteria. A history of schizophrenia (meeting DSM-IV criteria).\n3. History of severe drug or alcohol abuse within the past year;\n4. Any significant systemic illness or unstable medical condition that may make it difficult to comply with the protocol, such as severe autoimmune diseases or a history of cancer.\n5. Have significant hearing, visual, or cognitive impairments, or are unable to participate in interviews in a meaningful way.","8 Years",{"count":353,"type":20},20,[133],"Carry out precise and effective neuromodulation interventions, and develop new neuromodulation technologies for sleep disorders. Use phototherapy, transcranial electrical\u002Fmagnetic stimulation and other therapies to conduct self-controlled intervention studies on insomnia, narcolepsy, and rapid eye movement sleep behavior disorder .",[357,29,358],"Insomnia Chronic","REM Sleep Behavior Disorder","2025-02-11",{"date":361,"type":40},"2025-02-14",{"date":363,"type":40},"2025-02-01",{"date":365,"type":20},"2026-12-31",{"name":367,"class":148},"Second Affiliated Hospital of Soochow University",{"id":369,"slug":370,"hasResults":11,"nctId":371,"briefTitle":372,"officialTitle":372,"acronym":373,"eligibilityCriteria":374,"healthyVolunteers":106,"sex":16,"minAge":375,"maxAge":376,"enrollmentInfo":377,"targetDuration":4,"studyType":86,"phases":4,"briefSummary":379,"conditions":380,"keywords":4,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":381,"lastUpdatePostDateStruct":382,"startDateStruct":384,"completionDateStruct":386,"leadSponsor":388,"locationsCount":98},"100576521","genetic-and-clinical-characterization-of-type-1-and-2-narcolepsy-in-adult-and-pediatric-black-and-north-african-populations-100576521","NCT06786377","Genetic and Clinical Characterization of Type 1 and 2 Narcolepsy in Adult and Pediatric Black and North African Populations","NarcoGen","Inclusion Criteria:\n\nNarcolepsy patients:\n\n* Individuals of black and North African origin diagnosed with NT1 or NT2.\n* Age ≥ 6 years\n* Clinical confirmation of narcolepsy according to the criteria of the International Classification of Sleep Disorders (ICSD-3).\n* Signature of informed consent by the adult patient or both holders of parental authority for minor patients.\n\nControl subjects:\n\n* Volunteers without pathology related to the study from the same ethnic or related groups with the aim of reaching two matched control subjects for each case.\n* Age ≥ 6 years\n* Signature of informed consent by the adult subject or both holders of parental authority for minor subjects.\n\nExclusion Criteria:\n\n* Individuals unable to understand the protocol or unwilling to participate.","6 Years","21 Years",{"count":378,"type":20},200,"Narcolepsy type 1 (NT1) is a neurological disorder characterized by excessive daytime sleepiness, cataplexy, sleep paralysis, and hallucinations while awake. It results from the loss of orexin-producing neurons in the hypothalamus, leading to a deficiency of the neuropeptide orexin\u002Fhypocretin. Studies show differences in the clinical presentation of NT1 between Caucasian and African American populations, highlighting the importance of research into genetic and clinical characteristics specific to Black and North African populations.\n\nA genetic study in these populations could identify novel genes associated with NT1 and NT2, providing crucial information for personalized diagnosis and treatment. This would fill a knowledge gap and promote more effective interventions for individuals of African descent, contributing to a better understanding of narcolepsy globally.",[29],"2025-01-15",{"date":383,"type":40},"2025-01-22",{"date":385,"type":20},"2025-01-30",{"date":387,"type":20},"2026-01-30",{"name":389,"class":148},"Assistance Publique - Hôpitaux de Paris",{"id":391,"slug":392,"hasResults":11,"nctId":393,"briefTitle":394,"officialTitle":395,"acronym":4,"eligibilityCriteria":396,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":397,"enrollmentInfo":398,"targetDuration":400,"studyType":86,"phases":4,"briefSummary":401,"conditions":402,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":403,"lastUpdatePostDateStruct":404,"startDateStruct":406,"completionDateStruct":408,"leadSponsor":410,"locationsCount":411},"100431581","child-and-adolescent-registry-for-participants-with-narcolepsy-100431581","NCT04899947","Child and Adolescent Registry for Participants With Narcolepsy","Children, Adolescents and Their Providers: the Narcolepsy Assessment Partnership (CATNAPTM)","Inclusion Criteria:\n\n* Any child or adolescent with a physician-confirmed diagnosis of narcolepsy\n* Age less than 18 years\n* Willing to participate in the Registry and complete the informed consent form\n* Able to participate in English based registry\n\nExclusion Criteria:\n\n* Age 18 years or more\n* Fail to complete the informed consent form","17 Years",{"count":399,"type":20},500,"4 Years","CATNAP is a patient registry designed to improve the understanding of the natural history of narcolepsy in pediatric patients. Descriptive statistics on disease characteristics will be performed.\n\nThe study has 16 active clinical sites and a virtual site that widens participation to anywhere in the United States. For more information about the study or to access the Online Patient Enrollment System, visit the CATNAP website: https:\u002F\u002Fcatnap.healthie.net\u002Fwelcome or email catnap@pulseinfoframe.com. The Online Patient Enrollment System, CATNAP website, can also be found in the references section.",[29],"2024-08-13",{"date":405,"type":40},"2024-08-15",{"date":407,"type":40},"2020-10-10",{"date":409,"type":20},"2024-10-01",{"name":177,"class":47},25,{"id":413,"slug":414,"hasResults":11,"nctId":415,"briefTitle":416,"officialTitle":417,"acronym":4,"eligibilityCriteria":418,"healthyVolunteers":11,"sex":82,"minAge":4,"maxAge":4,"enrollmentInfo":419,"targetDuration":421,"studyType":86,"phases":4,"briefSummary":422,"conditions":423,"keywords":426,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":434,"lastUpdatePostDateStruct":435,"startDateStruct":437,"completionDateStruct":439,"leadSponsor":441,"locationsCount":122},"100547857","sunosi-solriamfetol-pregnancy-registry-100547857","NCT06413420","SUNOSI® (Solriamfetol) Pregnancy Registry","SUNOSI® (Solriamfetol) Pregnancy Registry: An Observational Study on the Safety of Solriamfetol Exposure in Pregnant Women and Their Offspring","Inclusion Criteria:\n\n* Pregnant women of any age\n* Diagnosed with narcolepsy or obstructive sleep apnea OR has taken solriamfetol or other wake promoting medications or stimulants during pregnancy\n* Resident of a country where solriamfetol is available for the treatment of excessive daytime sleepiness (EDS) associated with narcolepsy or OSA\n* Provides written informed consent to participate in the study\n* Authorization for her HCP(s) to provide data to the registry\n\nExclusion Criteria:\n\n* Occurrence of pregnancy outcome prior to first contact with the registry coordination center (RCC)\n* Inclusion of a prior pregnancy in the main analysis population",{"count":420,"type":20},1731,"12 Months","The SUNOSI (solriamfetol) Pregnancy Registry is a prospective, multi-country, observational study to evaluate the safety of solriamfetol exposure during pregnancy in women with a diagnosis of narcolepsy or obstructive sleep apnea (OSA).",[29,424,425],"Obstructive Sleep Apnea","Pregnant Women and Their Offspring",[427,428,429,29,424,430,431,432,433],"Solriamfetol","SUNOSI","Axsome","Non-stimulant therapy","Dopamine norepinephrine reuptake inhibitor","Pregnancy outcomes","Infant outcomes","2024-05-09",{"date":436,"type":40},"2024-05-14",{"date":438,"type":40},"2019-07-31",{"date":440,"type":20},"2029-09",{"name":442,"class":47},"Axsome Therapeutics, Inc.",{"id":444,"slug":445,"hasResults":11,"nctId":446,"briefTitle":447,"officialTitle":448,"acronym":4,"eligibilityCriteria":449,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":450,"targetDuration":4,"studyType":86,"phases":4,"briefSummary":451,"conditions":452,"keywords":453,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":454,"lastUpdatePostDateStruct":455,"startDateStruct":457,"completionDateStruct":459,"leadSponsor":461,"locationsCount":4},"100506157","discovering-factors-in-narcolepsy-patients-clinical-research-experiences-100506157","NCT05870735","Discovering Factors in Narcolepsy Patients' Clinical Research Experiences","The Patient Voice in Narcolepsy Clinical Trials: Reflections on Experiences and Outcomes","Inclusion Criteria:\n\n* Patient is at least 18 years of age\n* Patient is able and willing to comply with the treatment\u002Ffollow-up schedule and requirements\n* Patient must provide written informed consent\n\nExclusion Criteria:\n\n* Women who are pregnant, intend to become pregnant, or are lactating\n* Inability to perform regular electronic reporting\n* Participants who are vulnerable to any intervention",{"count":399,"type":20},"An observational trial can provide a platform for patients to share experiences and perspectives on living with narcolepsy, which can inform the development of new treatments and support programs.\n\nOverall, an observational clinical trial is an important tool for advancing the understanding of narcolepsy and improving outcomes for patients.",[29],[29],"2023-05-12",{"date":456,"type":40},"2023-05-23",{"date":458,"type":20},"2024-06",{"date":460,"type":20},"2026-06",{"name":462,"class":47},"Power Life Sciences Inc.",{"id":464,"slug":465,"hasResults":11,"nctId":466,"briefTitle":467,"officialTitle":467,"acronym":468,"eligibilityCriteria":469,"healthyVolunteers":106,"sex":16,"minAge":268,"maxAge":470,"enrollmentInfo":471,"targetDuration":473,"studyType":86,"phases":4,"briefSummary":474,"conditions":475,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":477,"lastUpdatePostDateStruct":478,"startDateStruct":480,"completionDateStruct":482,"leadSponsor":483,"locationsCount":98},"100387916","international-swiss-primary-hypersomnolence-and-narcolepsy-cohort-study-100387916","NCT04330963","International Swiss Primary Hypersomnolence and Narcolepsy Cohort Study","iSPHYNCS","Inclusion Criteria:\n\nStudy participants:\n\n* Subjective complaints of Excessive daytime sleepiness (EDS) and\u002For Hypersomnia (H) as defined above\n* EDS and\u002For H present daily or almost daily for at least 1 month prior to the consultation\n* Ability and consent to undergo electrophysiological routine assessment\n* Ability to give informed consent\n\nHealthy controls:\n\n* Age and gender matched healthy subjects\n* Including blood related relatives of study participants\n* Ability and consent to undergo electrophysiological routine assessment\n* Ability to give informed consent\n\nControls with Sleep disordered breathing (SDB):\n\n* Subjective complaints of EDS with Epworth Sleepiness Scale (ESS) \\> 10 (adults) and\u002For H due to SDB: Presence of clinically significant and untreated obstructive sleep apnea (OSA) as determined by the investigator with an apnea-hypopnea-index \\>30\u002Fh\n* Multiple sleep-latency test (MSLT) mean sleep latency ≤ 8min\n* Subjective and objective improvement of EDS and\u002For H within 3 months after treatment with\n* Positive airway pressure (PAP) therapy with documented\n\n  * Reduction of apnea-hypopnea index below \\\u003C10\u002Fh\n  * Reduction of ESS by ≥ 25%\n  * MSLT mean Sleep Latency \\> 12min\n* Ability and consent to undergo electrophysiological routine assessment\n* Ability to give informed consent\n\nExclusion Criteria:\n\nStudy participants and controls:\n\n* SDB for study participants and healthy controls: Presence of clinically significant and untreated obstructive sleep apnea (OSA) or central sleep apnea (CSA) as determined by the investigator or documented previously; or documentation of one of the following:\n\n  * Apnea index (AI) \\> 10 if on OSA treatment or untreated; or\n  * Clinically significant hypoventilation; or\n  * Noncompliance with primary OSA therapy\n  * except if NT1 has been diagnosed including decreased or missing cerebrospinal fluid (CSF) hypocretin\n* SDB for control population with SDB:\n\n  * Central Sleep Apnea (CSA)\n  * Noncompliance with primary OSA therapy and\u002For\n  * No reported improvement of EDS and\u002For H within 3 months of positive airway pressure (PAP) treatment\n* The following disorders\u002Fconditions that on clinical grounds are considered to be the cause of EDS \u002F H\n\n  * Other sleep disorders (e.g. Restless legs syndrome (RLS) with periodic leg movement syndrome (PLMS), sleepwalking, clear-cut circadian disorder)\n  * Other neurological disorders (e.g. stroke, multiple sclerosis, parkinsonism, severe traumatic brain injury)\n  * (Auto-)immune and systemic disorders (such as Hashimoto Thyroiditis, Chron's Disease, ulcerous colitis, Diabetes mellitus type I, Systemic lupus erythematosus)\n  * Malignancy (except: Status in Remission for at least \\> 10 years)\n  * Instable psychiatric disorder (e.g. acute psychotic, acute suicidal, episode of major depression requiring in-hospital treatment, active substance abuse)\n  * Active infectious disease at screening\n  * Permanent medications \u002F drugs\n* Chronic infectious diseases (such as Hepatitis B\u002FC, HIV)\n* Chronic use of antibiotics\n* Recent use (\\\u003C 8 weeks) of immune-modulating drugs\n\nHealthy controls additional:\n\n* Subjective complaints of EDS and \u002F or H\n* ESS \\> 10\n* Polysomnography (PSG) with AI \\> 10\u002Fh and \u002F or PLMS Index \\> 30\u002Fh\n* MSLT mean Sleep Latency \\\u003C 12 min","70 Years",{"count":472,"type":20},600,"36 Months","Swiss Primary Hypersomnolence and Narcolepsy Cohort Study (SPHYNCS) is a cohort study on disease presentation and long-term course with an exploratory approach to detect biomarkers.",[29,163,476],"Hypersomnolence Disorder","2023-04-17",{"date":479,"type":40},"2023-04-20",{"date":481,"type":40},"2020-01-06",{"date":39,"type":20},{"name":484,"class":148},"Insel Gruppe AG, University Hospital Bern",{"id":486,"slug":487,"hasResults":11,"nctId":488,"briefTitle":489,"officialTitle":490,"acronym":491,"eligibilityCriteria":492,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":493,"enrollmentInfo":494,"targetDuration":495,"studyType":86,"phases":4,"briefSummary":496,"conditions":497,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":505,"lastUpdatePostDateStruct":506,"startDateStruct":508,"completionDateStruct":510,"leadSponsor":512,"locationsCount":98},"100463950","mainz-register-of-patients-with-sleep-disorders-100463950","NCT05321355","Mainz Register of Patients With Sleep Disorders","Study on Disease Course and Quality of Life in Patients With Sleep Disorders (Mainz Sleep Registry)","MAINZ-SLEEPREG","Inclusion Criteria:\n\n* patients with narcolepsy\n* patients with other neurological sleep disorders\n\nExclusion Criteria:\n\n* patients aged \\\u003C18 years\n* patients who cannot provide informed consent and don't have a legal guardian","120 Years",{"count":399,"type":20},"3 Years","Prospective longitudinal observational registry study of all patients with sleep disorders treated in the Mainz Comprehensive Epilepsy and Sleep Medicine Center with the focus on the course of the disease and quality of life.",[498,499,29,500,501,502,163,503,504],"Sleep Disorder","Sleep Disorder Parasomnia","Sleep Apnea","Insomnia","Somnambulism","Restless Legs Syndrome","REM Behavior Disorder","2022-09-11",{"date":507,"type":40},"2022-09-15",{"date":509,"type":40},"2022-02-01",{"date":511,"type":20},"2030-01-31",{"name":513,"class":148},"Johannes Gutenberg University Mainz"]