[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"narcolepsy-type-2\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:narcolepsy-type-2":29},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,9,0,[8,65,92,105,130,154,178,200,223],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":26,"conditions":27,"keywords":30,"overallStatus":52,"whyStopped":4,"lastUpdateSubmitDate":53,"lastUpdatePostDateStruct":54,"startDateStruct":57,"completionDateStruct":59,"leadSponsor":61,"locationsCount":64},"100053299","phase-2-a-study-to-investigate-the-effects-of-cleminorexton-compared-with-placebo-in-the-treatment-of-participants-with-central-disorders-of-hypersomnolence-100053299",false,"NCT07598708","A Study to Investigate the Effects of Cleminorexton Compared With Placebo in the Treatment of Participants With Central Disorders of Hypersomnolence","A Randomized, Double-blind, 3-Arm Parallel Design Study to Investigate the Efficacy, Safety, Tolerability, and Pharmacokinetics of Cleminorexton Compared With Placebo in Participants With Central Disorders of Hypersomnolence","Key Inclusion Criteria:\n\n* 18-70 years of age\n* Body Mass Index (BMI) within the range ≥ 17.0 and ≤ 45 kg\u002Fm\\^2 (inclusive)\n* Meets the diagnostic criteria of Narcolepsy Type 1 (NT1) or Type 2 (NT2) according to International Classification of Sleep Disorders, 3rd edition, Text Revision edition (ICSD-3-TR) criteria\n* Is willing and able to discontinue all medications used for the treatment of narcolepsy\n* Is willing and able to adhere to additional protocol requirements\n\nKey Exclusion Criteria:\n\n* Medical disorder other than NT1 or NT2, that is associated with excessive daytime sleepiness (EDS)\n* Presence of significant cardiovascular, pulmonary, gastrointestinal, hepatic, renal, hematological, malignancy, endocrine, neurological or psychiatric disease","ALL","18 Years","70 Years",{"count":20,"type":21},222,"ESTIMATED","INTERVENTIONAL",[24,25],"PHASE2","PHASE3","Narcolepsy Type 1 (NT1) and Narcolepsy Type 2 (NT2) are rare conditions that make people feel very sleepy during the day (often referred to as excessive daytime sleepiness \\[EDS\\]). People living with these conditions might find it hard to stay alert and pay attention when they are at school, working, driving, or performing other daily activities.\n\nWhile all conditions result in feeling sleepy, there are some differences in other common symptoms:\n\n* NT1: People with NT1 often feel very tired during the day and experience cataplexy. Cataplexy is a sudden loss of muscle strength, which can cause someone to collapse or lose control of their muscles for a short time. This is often triggered by strong emotions, such as laughter or surprise. They may also have trouble sleeping well at night.\n* NT2: People with NT2 feel sleepy during the day, just like NT1, but they do not have cataplexy.\n\nOrexin is a protein in the brain that helps coordinate a system that plays an important role in helping people to stay awake during the daytime. Cleminorexton is designed to mimic the action of orexin. The purpose of this study is to see how safe and tolerable cleminorexton is in NT1 and NT2 and learn about what the drug does to the body. Another goal of the study is to see if cleminorexton can help people with NT1 and NT2 feel less sleepy and make other symptoms better.",[28,29],"Narcolepsy Type 1","Narcolepsy Type 2",[31,32,33,34,35,36,37,38,39,40,41,42,43,44,45,46,28,29,47,48,49,50,51],"NT1","NT2","Excessive Daytime Sleepiness","Orexin Receptor 2 agonist","Central Disorders of Hypersomnia","Disorders of Excessive Somnolence","Dyssomnias","Nervous System Diseases","Mental Disorders","Hypersomnia","Hypersomnolence","Sleep Wake Disorders","Sleep Disorder","Sleep","Sleepiness","Cataplexy","Orexin","ORX750","Cleminorexton","Narcolepsy","SAPPHIRE","RECRUITING","2026-07-09",{"date":55,"type":56},"2026-07-13","ACTUAL",{"date":58,"type":56},"2026-05-29",{"date":60,"type":21},"2027-12-31",{"name":62,"class":63},"Centessa Pharmaceuticals (UK) Limited","INDUSTRY",7,{"id":66,"slug":67,"hasResults":11,"nctId":68,"briefTitle":69,"officialTitle":70,"acronym":71,"eligibilityCriteria":72,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":73,"targetDuration":4,"studyType":22,"phases":75,"briefSummary":76,"conditions":77,"keywords":78,"overallStatus":52,"whyStopped":4,"lastUpdateSubmitDate":82,"lastUpdatePostDateStruct":83,"startDateStruct":85,"completionDateStruct":87,"leadSponsor":89,"locationsCount":91},"100631573","phase-3-a-study-to-evaluate-the-efficacy-and-safety-of-alks-2680-in-adults-with-narcolepsy-type-2-100631573","NCT07502443","A Study to Evaluate the Efficacy and Safety of ALKS 2680 in Adults With Narcolepsy Type 2","A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of ALKS 2680 in Adults With Narcolepsy Type 2 (Brilliance NT2 Study 303)","Brilliance NT2","Inclusion Criteria:\n\n* Is willing and able, in the opinion of the Investigator, to understand and comply with protocol requirements, including the following: lifestyle considerations and restrictions, adherence to contraception guidance, adherence to actigraphy and diary requirements, if receiving treatment for OSA, adherence to primary OSA therapy over the 30 days prior to Visit 1, and throughout the study, including during overnight visits.\n* Meets the diagnostic criteria of NT2 according to ICSD-3-TR guidelines, confirmed by diagnostic evaluations (either PSG\u002FMSLT).\n\nExclusion Criteria:\n\n* Has another comorbid sleep disorder or condition that may influence the sleep-wake cycle.\n* Has a history or presence of other clinically significant (treated or untreated) illness, disease, abnormality, or surgical procedure that, in the opinion of the Investigator, might compromise participant safety, interfere with any study assessment, or affect the participant's ability to complete the study.\n* Is currently enrolled in another interventional clinical trial or has received any investigational drug or used any interventional investigational device within 30 days prior to Visit 1. Participants previously enrolled in Study ALKS 2680-202 are not eligible for enrollment.\n* Is currently pregnant, breastfeeding, or is planning to become pregnant during the study",{"count":74,"type":21},176,[25],"The purpose of this study is to measure decreases in daytime sleepiness, and disease symptoms in participants with Narcolepsy Type 2 (NT2) when taking ALKS 2680 tablets compared with placebo tablets.",[29],[29,32,44,79,80,81],"Sleep disorder","orexin-2 receptor agonist","excessive daytime sleepiness","2026-06-30",{"date":84,"type":56},"2026-07-02",{"date":86,"type":56},"2026-04-22",{"date":88,"type":21},"2027-06",{"name":90,"class":63},"Alkermes, Inc.",19,{"id":93,"slug":4,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":94,"targetDuration":4,"studyType":22,"phases":95,"briefSummary":26,"conditions":96,"keywords":97,"overallStatus":52,"whyStopped":4,"lastUpdateSubmitDate":98,"lastUpdatePostDateStruct":99,"startDateStruct":101,"completionDateStruct":102,"leadSponsor":103,"locationsCount":104},"100642941",{"count":20,"type":21},[24,25],[28,29],[31,32,33,34,35,36,37,38,39,40,41,42,43,44,45,46,28,29,47,48,49,50,51],"2026-06-29",{"date":100,"type":56},"2026-07-01",{"date":58,"type":56},{"date":60,"type":21},{"name":62,"class":63},5,{"id":106,"slug":107,"hasResults":11,"nctId":108,"briefTitle":109,"officialTitle":110,"acronym":4,"eligibilityCriteria":111,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":112,"enrollmentInfo":113,"targetDuration":4,"studyType":22,"phases":115,"briefSummary":116,"conditions":117,"keywords":119,"overallStatus":52,"whyStopped":4,"lastUpdateSubmitDate":121,"lastUpdatePostDateStruct":122,"startDateStruct":123,"completionDateStruct":125,"leadSponsor":127,"locationsCount":129},"100642659","phase-2-a-study-of-tak-360-in-people-with-narcolepsy-or-idiopathic-hypersomnia-100642659","NCT07646678","A Study of TAK-360 in People With Narcolepsy or Idiopathic Hypersomnia","A Long-term Extension Trial to Evaluate the Safety and Tolerability of TAK-360 in Participants With Selected Central Hypersomnia Conditions","Key Inclusion Criteria:\n\n1. Participant is willing and able to understand and fully comply with trial procedures and requirements.\n2. Participant has a confirmed diagnosis of either NT1, NT2, or IH, and has completed the treatment period of a parent TAK-360 trial.\n3. Participant has provided informed consent (that is, in writing, documented via a signed and dated informed consent form (ICF) and any required privacy authorization before the initiation of any trial procedures.\n\nKey Exclusion Criteria:\n\n1. Participant has a positive pregnancy test or is lactating\u002Fbreastfeeding.\n2. Participant has a risk of suicide according to endorsement of item 4 or 5 on the Columbia Suicide Severity Rating Scale (C-SSRS).\n3. The participant has developed a new medical disorder associated with excessive daytime sleep (EDS).\n4. Participant has developed (within the last 6 months) gastrointestinal disease that is expected to influence the absorption of drugs.\n5. Participant has developed a new history of seizures.\n6. Participant has experienced clinically significant head injury, per investigator opinion.\n7. Participant has developed a history of cerebral ischemia, transient ischemic attack (less than \\[\\\u003C\\] 5 years ago), or cerebral haemorrhage.\n8. Participant has developed a history of myocardial infarction, clinically significant coronary artery disease, clinically significant angina, clinically significant cardiac rhythm abnormality, or heart failure.\n9. The participant has been diagnosed with medically significant thyroid disease, known functional hepatic impairment, or other severe chronic medical condition other than the central hypersomnolence disorder.\n10. Participant has developed a history of cancer in the past 5 years.","71 Years",{"count":114,"type":21},500,[24,25],"Central hypersomnia conditions are a group of sleeping disorders where the brain has trouble keeping a person awake during the day (called excessive daytime sleepiness or EDS). These conditions usually include narcolepsy (type 1 and 2) and idiopathic hypersomnia (IH). Narcolepsy type 1 (NT1) includes sudden muscle weakness while you stay awake, called cataplexy, often triggered by strong emotions. Narcolepsy type 2 (NT2) does not include cataplexy. People with narcolepsy typically feel refreshed by short naps. People with IH feel extremely sleepy during the day, and do not feel refreshed by sleep. Waking up from sleep is difficult. This is common in the morning and also when waking up from long naps.\n\nThe study wants to learn about TAK-360 when taken over a long time period; this is called a long-term extension or LTE study. The main aim of this LTE study is to find out how well participants with NT1, NT2, and IH tolerate TAK-360 over a longer period (long-term tolerability) and to learn how safe TAK-360 is when given over a longer period of time (long-term safety).\n\nParticipants who completed one of the TAK-360 parent studies can join this study if they meet the study rules. Parent studies include TAK-360-2001(NCT06952699), TAK-360-2002 (NCT06812078), or other TAK-360 studies that evaluate the TAK-360 medicine. All participants will receive TAK-360 in this study. They will either receive the same dose as they did in the parent study, or the closest dose available in this LTE study. Participants who received placebo (the placebo looks just like TAK-360 but does not have any medicine in it) in their parent study will receive one of the TAK-360 doses available in this study. Placebo will only be used to not reveal the dose of TAK-360 from parent studies to investigator, participants, and sponsor. Sponsor, investigators and participants will not know which TAK-360 dose was used in the LTE study as long as the parent study is ongoing.\n\nThe participants will have to visit the clinic multiple times during this study.",[118,28,29],"Idiopathic Hypersomnia",[120],"Drug Therapy","2026-06-25",{"date":82,"type":56},{"date":124,"type":56},"2026-06-11",{"date":126,"type":21},"2031-06-15",{"name":128,"class":63},"Takeda",1,{"id":131,"slug":132,"hasResults":11,"nctId":133,"briefTitle":134,"officialTitle":135,"acronym":4,"eligibilityCriteria":136,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":137,"targetDuration":4,"studyType":22,"phases":139,"briefSummary":140,"conditions":141,"keywords":142,"overallStatus":52,"whyStopped":4,"lastUpdateSubmitDate":145,"lastUpdatePostDateStruct":146,"startDateStruct":148,"completionDateStruct":150,"leadSponsor":152,"locationsCount":153},"100589306","phase-2-a-study-of-tak-360-in-adults-with-narcolepsy-without-cataplexy-nt2-100589306","NCT06952699","A Study of TAK-360 in Adults With Narcolepsy Without Cataplexy (NT2)","A Randomized, Double-Blinded, Placebo-Controlled, Dose-Finding, Adaptive Trial to Evaluate the Safety, Tolerability, and Efficacy of TAK-360 in Participants With Narcolepsy Without Cataplexy (NT2)","Key Inclusion Criteria:\n\n1. The participant weighs greater than equal or to (≥)40 kilograms (kg) and has a body mass index (BMI) between 16 and 38 kilograms per meter square (kg\u002Fm\\^2) \\[inclusive\\].\n2. The participant has a documented, current diagnosis of NT2.\n\nKey Exclusion Criteria:\n\n1. The participant has a current medical disorder associated with excessive daytime sleepiness (EDS) other than NT2.\n2. The participant has medically significant thyroid disease.\n3. The participant has a history of cancer in the past 5 years. (This exclusion does not apply to participants with carcinoma in situ \\[such as basal cell carcinoma\\] that has been treated and is stable, or who have been stable without further treatment. These participants may be included after approval by the medical monitor).\n4. The participant has any of the following viral infections based on a positive test result: Hepatitis B surface antigen (at screening), hepatitis C virus (HCV) antibody (at screening), human immunodeficiency virus (HIV) antibody\u002Fantigen (at screening).\n5. The participant has a clinically significant history of head injury or head trauma.\n6. The participant has history of epilepsy, seizure, or convulsion (exception for a single febrile seizure in childhood).\n7. The participant has a history of cerebral ischemia, transient ischemic attack (\\\u003C5 years from screening), intracranial aneurysm, or arteriovenous malformation.",{"count":138,"type":21},88,[24],"Narcolepsy without cataplexy or Narcolepsy Type 2 (NT2) is a lifelong condition that makes people very sleepy during the day, regardless of how much sleep they get at night. People with NT2 may fall asleep suddenly, have trouble staying awake during the day, or may not be able to sleep well at night. They may have difficulty thinking clearly, paying attention, or remembering things, during the day. These symptoms can make daily activities like driving, working, or caring for their families challenging, impacting their quality of life. Orexin is a chemical made in the brain that helps keep a person awake and alert. TAK-360 acts like orexin. Previous studies have shown that medicines that act like orexin may keep people awake.\n\nThe main aim of this study is to learn how safe TAK-360 is and how well adults with NT2 tolerate it. Researchers also want to find out if TAK-360 can help people with NT2 stay awake and determine the right dosage needed to do that.\n\nParticipants will be randomly (by chance, like drawing names from a hat) assigned to get either TAK-360 or placebo in the treatment period. The placebo is a pill that looks just like TAK-360 but does not have any medicine in it. Using a placebo helps researchers learn about the real effect of the treatment.",[29],[143,32,144],"Narcolepsy without Cataplexy","TAK-360","2026-06-16",{"date":147,"type":56},"2026-06-17",{"date":149,"type":56},"2025-05-06",{"date":151,"type":21},"2026-08-20",{"name":128,"class":63},52,{"id":155,"slug":156,"hasResults":11,"nctId":157,"briefTitle":158,"officialTitle":158,"acronym":159,"eligibilityCriteria":160,"healthyVolunteers":11,"sex":16,"minAge":161,"maxAge":4,"enrollmentInfo":162,"targetDuration":4,"studyType":164,"phases":4,"briefSummary":165,"conditions":166,"keywords":167,"overallStatus":52,"whyStopped":4,"lastUpdateSubmitDate":169,"lastUpdatePostDateStruct":170,"startDateStruct":172,"completionDateStruct":174,"leadSponsor":176,"locationsCount":177},"100615937","epidemiology-of-narcolepsy-type-1-and-type-2-in-spain-100615937","NCT07299097","Epidemiology of Narcolepsy Type 1 and Type 2 in Spain","HYPNOS","\\- Core Group:\n\nInclusion Criteria:\n\n1. Participants with NT1 or NT2 following International Classification of Sleep Disorders, 3rd Edition (ICSD-3) or ICSD-3 text revision (ICSD-3-TR) criteria who are alive at any point during 2023 or 2024.\n2. Any age, ethnicity and nationality.\n3. Treated \u002F under follow-up in the study site and residing in the hospitals' reference areas. Consideration will be given if participants have changed their address or reached adulthood.\n\nExclusion Criteria\n\n1\\. NT1 or NT2 participants who do not reside in the hospitals' reference areas.\n\n\\- Supplementary Group:\n\nInclusion criteria:\n\n1. Confirmation to have a diagnosis of NT1 or NT2 by a specialist.\n2. Participants greater than equal to (≥) 18 years or parents of narcolepsy participants under 18 years of age.\n3. Any gender, ethnicity or nationality.\n4. Residence in Spain.\n\nExclusion criteria:\n\n1\\. Participants without a confirmed NT1 or NT2 diagnosis by a specialist.","0 Years",{"count":163,"type":21},100,"OBSERVATIONAL","The main purpose of this study is to find out how many people in Spain have been diagnosed with narcolepsy type 1 and type 2, and how many new participants are diagnosed each year. Narcolepsy is a rare sleep disorder that causes excessive daytime sleepiness. The researchers will look at medical records from hospitals across Spain to count participants with these conditions and understand patterns in diagnosis over time.",[28,29],[168],"Drug therapy","2026-05-12",{"date":171,"type":56},"2026-05-15",{"date":173,"type":56},"2025-12-02",{"date":175,"type":21},"2026-07-31",{"name":128,"class":63},10,{"id":179,"slug":180,"hasResults":11,"nctId":181,"briefTitle":182,"officialTitle":183,"acronym":184,"eligibilityCriteria":185,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":186,"enrollmentInfo":187,"targetDuration":4,"studyType":22,"phases":189,"briefSummary":190,"conditions":191,"keywords":4,"overallStatus":52,"whyStopped":4,"lastUpdateSubmitDate":86,"lastUpdatePostDateStruct":192,"startDateStruct":194,"completionDateStruct":196,"leadSponsor":198,"locationsCount":199},"100573929","phase-2-a-study-of-orx750-in-participants-with-narcolepsy-and-idiopathic-hypersomnia-100573929","NCT06752668","A Study of ORX750 in Participants With Narcolepsy and Idiopathic Hypersomnia","A Phase 2a, Randomized, Double-blind, Placebo-controlled Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of ORX750 in Subjects With Narcolepsy and Idiopathic Hypersomnia (CRYSTAL-1)","CRYSTAL-1","Inclusion Criteria:\n\n* 18-65 years of age\n* BMI ≥17 and ≤37 kg\u002Fm2\n* Meets the diagnostic criteria of Narcolepsy Type 1 (NT1), Type 2 (NT2) or Idiopathic Hypersomnia (IH) according to ICSD-3-TR criteria\n* Is willing and able to discontinue all medications used for the treatment of narcolepsy or idiopathic hypersomnia\n* Is willing and able to adhere to additional protocol requirements\n\nExclusion Criteria:\n\n* A medical disorder other than NT1, NT2, or IH that is associated with excessive daytime sleepiness (EDS).\n* Presence of significant cardiovascular, pulmonary, gastrointestinal, hepatic, renal, hematological, malignancy, endocrine, neurological or psychiatric disease","65 Years",{"count":188,"type":21},248,[24],"Narcolepsy Type 1 (NT1), Narcolepsy Type 2 (NT2), and Idiopathic Hypersomnia (IH) are rare conditions that make people feel very sleepy during the day (often referred to as excessive daytime sleepiness \\[EDS\\]). People living with these conditions might find it hard to stay alert and pay attention when they are at school, working, driving, or performing other daily activities.\n\nWhile all conditions result in feeling sleepy, there are some differences in other common symptoms:\n\n* NT1: People with NT1 often feel very tired during the day and experience cataplexy. Cataplexy is a sudden loss of muscle strength, which can cause someone to collapse or lose control of their muscles for a short time. This is often triggered by strong emotions, such as laughter or surprise. They may also have trouble sleeping well at night.\n* NT2: People with NT2 feel sleepy during the day, just like NT1, but they do not have cataplexy.\n* IH: People with IH feel tired during the day, even after sleeping a lot at night. They may sleep for long periods, take long naps, and find it hard to wake up.\n\nOrexin is a protein in the brain that helps coordinate a system that plays an important role in helping people to stay awake during the daytime. Cleminorexton (also known as ORX750) is designed to mimic the action of orexin. The purpose of this study is to see how safe and tolerable ORX750 is in NT1, NT2, and IH, and learn about what the drug does to the body. Another goal of the study is to see if ORX750 can help people with NT1, NT2, and IH feel less sleepy and make other symptoms better.",[28,29,118],{"date":193,"type":56},"2026-04-27",{"date":195,"type":56},"2024-12-23",{"date":197,"type":21},"2026-12",{"name":62,"class":63},37,{"id":201,"slug":202,"hasResults":11,"nctId":203,"briefTitle":204,"officialTitle":205,"acronym":4,"eligibilityCriteria":206,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":186,"enrollmentInfo":207,"targetDuration":4,"studyType":22,"phases":209,"briefSummary":210,"conditions":211,"keywords":212,"overallStatus":52,"whyStopped":4,"lastUpdateSubmitDate":214,"lastUpdatePostDateStruct":215,"startDateStruct":217,"completionDateStruct":219,"leadSponsor":221,"locationsCount":222},"100600375","phase-2-a-long-term-extension-study-of-orx750-in-participants-with-narcolepsy-and-idiopathic-hypersomnia-100600375","NCT07096674","A Long-term Extension Study of ORX750 in Participants With Narcolepsy and Idiopathic Hypersomnia","A Phase 2, Long-term Extension Study of the Safety and Efficacy of ORX750 in Participants With Narcolepsy and Idiopathic Hypersomnia Who Completed a Sponsored ORX750 Clinical Trial","Inclusion Criteria:\n\n* Diagnosis of narcolepsy (NT1 or NT2) or IH who was eligible for and completed the full treatment period in the eligible parent study ORX750-0201 (CRYSTAL-1)\n* Is willing and able to adhere to additional protocol requirements\n\nExclusion Criteria:\n\n* Development of any new disease\u002Fdisorder that in the opinion of the investigator would make the participant unable to continue the study\n* Unable to refrain from excluded medications, including those used for treatment of narcolepsy or idiopathic hypersomnia",{"count":208,"type":21},90,[24],"This study is a long-term extension (LTE) of the parent Study ORX750 0201, and will provide long-term open-label safety, tolerability, and efficacy of ORX750 in participants with narcolepsy type 1 (NT1), narcolepsy type 2 (NT2), and idiopathic hypersomnia (IH).",[28,29,118],[31,32,213,50,28,29,118,33,34],"IH","2026-04-15",{"date":216,"type":56},"2026-04-16",{"date":218,"type":56},"2025-08-12",{"date":220,"type":21},"2026-04-30",{"name":62,"class":63},24,{"id":224,"slug":225,"hasResults":11,"nctId":226,"briefTitle":227,"officialTitle":228,"acronym":4,"eligibilityCriteria":229,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":230,"targetDuration":4,"studyType":22,"phases":232,"briefSummary":233,"conditions":234,"keywords":235,"overallStatus":52,"whyStopped":4,"lastUpdateSubmitDate":238,"lastUpdatePostDateStruct":239,"startDateStruct":241,"completionDateStruct":243,"leadSponsor":245,"locationsCount":246},"100575084","phase-2-a-long-term-study-of-alks-2680-in-subjects-with-narcolepsy-and-idiopathic-hypersomnia-100575084","NCT06767683","A Long-Term Study of ALKS 2680 in Subjects With Narcolepsy and Idiopathic Hypersomnia","An Open-Label, Long-Term Extension Study to Investigate the Safety, Tolerability, and Durability of Treatment Effect of ALKS 2680 in Subjects With Narcolepsy Type 1 and Type 2 and Idiopathic Hypersomnia","Inclusion Criteria:\n\n* Was eligible for and has completed end of treatment visit of ALKS 2680 eligible parent study in NT1, NT2 or IH. The current eligible studies are ALKS 2680-201 (Vibrance-1), ALKS 2680-202 (Vibrance-2) and ALKS 2680-203 (Vibrance-3)\n* Is willing and able, and in the opinion of the treating physician can safely discontinue any medications prescribed for the management of narcolepsy symptoms, as applicable, for 5 half-lives prior to Day 1 (for re-entry subjects), and for the duration of study (for all subjects)\n\nExclusion Criteria:\n\n* Developed a new clinically significant health condition, ECG or laboratory abnormality, in the opinion of the Investigator or Sponsor, may impact the subject's participation in the study\n* Is currently pregnant, breastfeeding, or planning to become pregnant during the study\n* Is currently enrolled in another clinical study (other than the parent study) or used any investigational drug or device within 30 days prior to Screening",{"count":231,"type":21},256,[24,25],"The purpose of this study is to continue to measure the safety, tolerability, and durability of treatment effect in subjects with Narcolepsy Type 1 (NT1), Narcolepsy Type 2 (NT2), or Idiopathic Hypersomnia (IH) when taking ALKS 2680 tablets.",[28,29,118],[50,28,29,31,32,80,236,237,81,213,118],"sleep","sleep disorder","2026-03-03",{"date":240,"type":56},"2026-03-04",{"date":242,"type":56},"2025-01-27",{"date":244,"type":21},"2028-06",{"name":90,"class":63},46]