[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100561476":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":29,"centralContacts":33,"locations":38,"responsibleParty":51,"collaborators":25,"id":53,"slug":54,"hasResults":55,"nctId":56,"briefTitle":57,"officialTitle":58,"acronym":59,"eligibilityCriteria":60,"healthyVolunteers":55,"sex":61,"minAge":62,"maxAge":63,"enrollmentInfo":64,"targetDuration":25,"studyType":67,"phases":68,"briefSummary":70,"conditions":71,"keywords":73,"overallStatus":76,"whyStopped":25,"lastUpdateSubmitDate":77,"lastUpdatePostDateStruct":78,"startDateStruct":81,"completionDateStruct":83,"leadSponsor":85,"locationsCount":86},{"fullName":5,"class":6},"University Hospital, Montpellier","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Solriamfetol","EXPERIMENTAL","Solriamfetol will be taken once a day upon awakening during 7-weeks",[13],"Drug: Solriamfetol",{"label":15,"type":16,"description":17,"interventionNames":18},"Placebo","PLACEBO_COMPARATOR","Placebo will be taken once a day upon awakening during 7-weeks",[19],"Drug: Placebo",[21,26],{"type":22,"name":9,"description":23,"armGroupLabels":24,"otherNames":25},"DRUG","Patient with a diagnostic of idiopathic hypersomnia (ICSD-3 criteria) will be randomized to receive solriamfetol or placebo for 7 weeks of treatment period. For the experimental arm, the dose will be progressively increased beginning at 75 mg to 300 mg according to tolerance to treatment.\n\nSolriamfetol will be taken once a day upon awakening Schema of dispensation\n\n1. One tablet of solriamfetol 75 mg per day for 1 week (week 1)\n2. 150 mg of solriamfetol per day for 2 weeks (weeks 2 and 3)\n3. According clinical judgment, Dose either maintained stable at 150 mg or increased to 300 mg per day for 2 weeks (weeks 4 and 5).\n4. Prescription at week 5: Dose maintained at 150 or 300 mg or reduced at 150 mg per day according to benefit and safety for 2 weeks.\n\nTreatment duration: 7 weeks treatment period.",[9],null,{"type":22,"name":15,"description":27,"armGroupLabels":28,"otherNames":25},"Patient with a diagnostic of idiopathic hypersomnia (ICSD-3 criteria) will be randomized to receive solriamfetol or placebo for 7 weeks of treatment period.\n\nPlacebo will be taken once a day upon awakening Schema of dispensation\n\n1. One tablet of placebo per day for 1 week (week 1)\n2. Two tablets of placebo per day for 2 weeks (weeks 2 and 3)\n3. According clinical judgment, Either maintained stable with 2 tablets or increased to 4 tablets per day for 2 weeks (weeks 4 and 5).\n4. Prescription at week 5: Dose maintained at 2 or 4 tablets or reduced at 2 tablets per day according to benefit and safety for 2 weeks.\n\nTreatment duration: 7 weeks placebo period.",[15],[30],{"name":31,"affiliation":5,"role":32},"Yves DAUVILLIERS, MD","PRINCIPAL_INVESTIGATOR",[34],{"name":31,"role":35,"phone":36,"phoneExt":25,"email":37},"CONTACT","+33467335219","y-dauvilliers@chu-montpellier.fr",[39],{"facility":40,"status":25,"city":41,"state":25,"zip":42,"country":43,"countryCode":44,"cosmosGeoPoint":45,"geoPoint":50,"contacts":25},"University Hospital of Montpellier","Montpellier","34295","France","FR",{"type":46,"coordinates":47},"Point",[48,49],3.87635,43.61093,{"lat":49,"lon":48},{"type":52,"investigatorFullName":25,"investigatorTitle":25,"investigatorAffiliation":25,"oldNameTitle":25,"oldOrganization":25},"SPONSOR","100561476","phase-2-efficacy-and-tolerance-of-solriamfetol-in-patients-affected-with-idiopathic-hypersomnia-100561476",false,"NCT06590662","Efficacy and Tolerance of Solriamfetol in Patients Affected with Idiopathic Hypersomnia.","A Randomized, Double-blind, Placebo-controlled Trial Comparing the Efficacy and Tolerance of Solriamfetol in Patients Affected with Idiopathic Hypersomnia.","SOLR-IH","Main inclusion criteria:\n\n* Age between 18 and 60 years-old\n* BMI between 18 and 30 kg\u002Fm2\n* Diagnostic of idiopathic hypersomnia (ICSD-3 criteria) made in the last 5 years, based on Polysomnography (PSG) and Multiple Sleep Latency Test (MSLT) results, showing either: a mean sleep latency (MSL) of ≤8 minutes and \\\u003C 2 SOREMPs and\u002For a 24-h long term polysomnography recording showing total sleep time \\>11h\u002F24 hours.\n* Apnea-hypopnea index (AHI) \\\u003C15\u002Fhour, Apnea index \\\u003C10\u002Fhour, micro-arousals index \\\u003C15\u002Fhour, Periodic limb movement (PLM) index associated with micro-arousals \\\u003C15\u002Fhour on the PSG and MSLT performed within the past 5 years.\n* Absence of sleep deprivation, assessed by actigraphy or sleep logs for the 7 days preceding study inclusion\n* ESS score ≥11 points\n* Written informed consent\n* National health insurance coverage\n* Understand, read and speaks French well\n* The participant agrees to follow the contraceptive requirements detailed in the protocol.\n\nMain non-inclusion criteria\n\n* Non-stabilized hypertension\n* To be at imminent risk of suicide or injury to self, others, or property, or the participant has attempted suicide within the past year before screening, or has positive answers on items number 4 or 5 on the Colombia-Suicide Severity Rating Scale (based on the 6 months before randomization).\n* Other psychiatric conditions in the past 6 months\n* Presence of other central nervous system diseases: neurodegenerative diseases, seizure disorders, or history of head trauma associated with loss of consciousness\n* Prior history of psychotic episodes\n* Psychostimulant treatment with modafinil, methylphenidate, mazindol, pitolisant, ongoing or within 15 days prior to visit 1\n* Treatment for obstructive sleep apnea-hypopnea syndrome ongoing or within 15 days prior to visit 1\n* Treatment with psychotropic drugs: neuroleptics (i.e. clozapine, olanzapine, aripiprazole, …), sedative hypnotics (benzodiazepines, zolpidem, zopiclone), central nervous system depressants (barbiturates, …), antidepressants (SSRI (e.g. fluoxetine, sertraline, paroxetine…), serotonin and norepinephrine reuptake inhibitors (SRNI : e.g. venlafaxine, duloxetine), Monoamine oxidase inhibitors), anxiolytic drugs, anticonvulsive therapy (i.e. topiramate, inhibitors of GHB dehydrogenase (i.e. valproate, ethosuximide, phenytoin), or drugs for pain (level 2 (e.g. codeine, tramadol), and level 3 (morphine and derivatives)), ongoing or within 30 days prior to visit 1.\n* Treatment with dopamine antagonist antiemetics except domperidone, Catechol-O-methyltransferase (COMT) inhibitors, or sedative antihistamines ongoing or within 30 days prior to visit 1\n\n  =\\> Of note, for all the above treatments: if patient has received such therapy, a washout-period of at least 15 days, or equivalent to 5 half-lives of the drug, prior to the inclusion in the study is required before starting treatment in this study. Of note, for antidepressants, a washout of at least 30 days should be required.\n* Previously treated with solriamfetol\n* History of chronic alcohol or drug abuse within the prior 12 months\n* Malignant neoplastic disease requiring therapy within 12 months prior to Visit 1 or clinically relevant\n* Heart failure, unstable hypertension or other cardiovascular disease compromising the patient's wellbeing or ability to participate in this study\n* Renal or hepatic impairment\n* No regular sleep at night: shift work or other continuous non-disease-related life conditions\n* Has received any other investigational drug within 30 days or 5 half-lives (whichever is longer) prior to screening or plans to use an investigational drug (other than the study intervention) during the study","ALL","18 Years","60 Years",{"count":65,"type":66},60,"ESTIMATED","INTERVENTIONAL",[69],"PHASE2","This Phase II clinical trial is a monocenter, double-blind, randomized, placebo-controlled study aimed at evaluate the efficacy and safety of solriamfetol from 75 to 300 mg per day in IH patients.\n\nPatients will be randomized (1:1) to receive either solriamfetol or placebo, with titration, every morning upon awakening during all treatment periods (Day 0 to Week 7).",[72],"Idiopathic Hypersomnia",[74,9,75],"Idiopathic hypersomnia","polysomnography","NOT_YET_RECRUITING","2024-09-09",{"date":79,"type":80},"2024-09-19","ACTUAL",{"date":82,"type":66},"2024-09-15",{"date":84,"type":66},"2027-06-01",{"name":5,"class":6},1]