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Study to Evaluate the Safety and Efficacy of ALKS 2680 in Subjects With Idiopathic Hypersomnia (Vibrance-3)","RECRUITING","2026-11","2026-06","2026-06-24","2025-05-22","Alkermes, Inc.","INDUSTRY",true,"The purpose of this study is to measure the safety and decrease in daytime sleepiness in subjects with Idiopathic Hypersomnia when taking ALKS 2680 tablets compared with placebo tablets",null,[19],"Idiopathic Hypersomnia",[19,21,22,23,24,25],"IH","sleep","sleep disorder","orexin-2 receptor agonist","excessive daytime sleepiness","INTERVENTIONAL","TREATMENT",[29],"PHASE2",{"count":31,"type":32},126,"ESTIMATED",[34,43],{"type":35,"name":36,"description":37,"armGroupLabels":38},"DRUG","ALKS 2680","Oral tablet containing ALKS 2680 for daily, oral administration",[39,40,41,42],"ALKS 2680 Dose 1- Part B","ALKS 2680, 10 mg- Part A","ALKS 2680, 14 mg -Part A","ALKS 2680, 18 mg- Part A",{"type":35,"name":44,"description":45,"armGroupLabels":46},"Placebo","Oral placebo tablet for daily 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ICSD-3-TR guidelines, confirmed by the diagnostic evaluations (PSG\u002FMSLT\u002Factigraphy) within the previous 10 years",[68,69,70,71],"Has another comorbid sleep disorder or condition that may influence the sleep-wake cycle","Has a history or presence at Visit 1 of other clinically significant (treated or untreated) illness, disease, abnormality, or surgical procedure that, in the opinion of the Investigator, might compromise subject safety, interfere with any study assessment, or affect the subject's ability to complete the study","Is currently enrolled in another clinical study or used any investigational drug or device within 30 days prior to Visit 1","Is currently pregnant, breastfeeding, or is planning to become pregnant during the study","Inclusion Criteria:\n\n* Is willing and able, in the opinion of the Investigator, to understand and comply with protocol requirements, including: 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 Idiopathic Hypersomnia according to ICSD-3-TR guidelines, confirmed by the diagnostic evaluations (PSG\u002FMSLT\u002Factigraphy) within the previous 10 years\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 at Visit 1 of other clinically significant (treated or untreated) illness, disease, abnormality, or surgical procedure that, in the opinion of the Investigator, might compromise subject safety, interfere with any study assessment, or affect the subject's ability to complete the study\n* Is currently enrolled in another clinical study or used any investigational drug or device within 30 days prior to Visit 1\n* Is currently pregnant, breastfeeding, or is 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BV","Netherlands",{"lat":387,"lon":388},52.5125,6.09444,{"facility":78,"status":8,"city":390,"zip":391,"country":392,"geoPoint":393},"Barcelona","8036","Spain",{"lat":394,"lon":395},41.38879,2.15899,{"facility":78,"status":8,"city":397,"zip":398,"country":392,"geoPoint":399},"Madrid","28036",{"lat":400,"lon":401},40.4165,-3.70256,{"facility":78,"status":8,"city":397,"zip":403,"country":392,"geoPoint":404},"28043",{"lat":400,"lon":401},[406,411],{"name":407,"role":408,"phone":409,"email":410},"Director, Global Clinical Services","CONTACT","888-235-8008 (US Only)","clinicaltrials@alkermes.com",{"name":407,"role":408,"phone":412,"email":410},"571-599-2702 (Global)",[414],{"name":415,"affiliation":13,"role":416},"Medical Director","STUDY_DIRECTOR",[],[419],{"label":420,"url":421},"Vibrance Study for IH","https:\u002F\u002FVibrancestudies.com",{"nct_id":4,"conditions":423,"biomarkers":424},[19],[],{"nct_id":4,"found":15,"summary":426,"prompt_version":436},{"design":427,"status":428,"heading":429,"summary":430,"follow_up":431,"word_count":432,"commitments":433,"compensation":434,"drugs_mentioned":435},"This interventional study is designed to compare ALKS 2680 to a placebo in about 126 participants. The phase of the study is not specified.","completed","A Study of ALKS 2680 for Idiopathic Hypersomnia","This study is testing a new oral tablet called ALKS 2680 to see how safe it is and how well it reduces daytime sleepiness in people with Idiopathic Hypersomnia (a condition causing extreme daytime sleepiness). You would be given either ALKS 2680 or a placebo (an inactive pill that looks like the study drug) to take daily. Researchers will measure changes in your daytime sleepiness using a scale called the Epworth Sleepiness Scale (ESS) over 8 weeks. To join, you need to be between 18 and 70 years old. The study is currently unclear on its recruitment status, but plans to enroll about 126 people.","The primary endpoint measures changes up to 8 weeks after starting treatment.",105,"You would take an oral tablet daily and follow specific lifestyle and contraception guidance. You would also need to adhere to actigraphy (a way to measure activity and sleep) and diary requirements.","Not stated in the trial record.",[36,44],"v2"]