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232-3333","aallen45@wisc.edu",{"name":711,"role":70,"phone":34,"phoneExt":34,"email":34},"David Plante",{"type":713,"investigatorFullName":34,"investigatorTitle":34,"investigatorAffiliation":34,"oldNameTitle":34,"oldOrganization":34},"SPONSOR","100631393","phase-3-a-phase-3-efficacy-and-safety-study-of-hbs-301-in-participants-with-idiopathic-hypersomnia-ih-100631393",false,"NCT07500090","A Phase 3 Efficacy and Safety Study of HBS-301 in Participants With Idiopathic Hypersomnia (IH)","A Phase 3, Randomized, Double-blind, Placebo-Controlled, Efficacy and Safety Study of HBS-301 in Participants With Idiopathic Hypersomnia (IH) Followed by an Open-label Extension","Inclusion Criteria:\n\n* Has a current documented diagnosis of IH per the International Classification of Sleep Disorders, Third Edition (ICSD-3) or Text Revision (ICSD-3-TR) criteria with confirmatory polysomnogram (PSG) with multiple sleep latency test (MSLT; and if applicable, a 24-hour PSG report or an actigraphy report with sleep log) on file that led to the diagnosis and was completed within the last 10 years.\n* Has EDS.\n* Has moderate to very severe symptoms of IH.\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 use of any treatment that could affect daytime sleepiness (including but not limited to stimulants, modafinil, and armodafinil) used on an as-needed basis 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.\n* Has a history of moderate or severe hepatic impairment.\n* Has a body surface area (BSA)-corrected estimated glomerular filtration rate (eGFR) \\\u003C60 mL\u002Fmin.\n* Has a known history of long QT syndrome or any significant history of a serious abnormality of the electrocardiogram (ECG).","ALL","18 Years",{"count":724,"type":725},248,"ESTIMATED","INTERVENTIONAL",[728],"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 adult participants (ages ≥18 years) with idiopathic hypersomnia (IH).",[731],"Idiopathic Hypersomnia",[733,734,735,736,737,738],"pitolisant","HBS-301","idiopathic hypersomnia","excessive daytime sleepiness","sleep inertia","fatigue","2026-08-11",{"date":741,"type":742},"2026-08-13","ACTUAL",{"date":744,"type":742},"2026-03-16",{"date":746,"type":725},"2028-10",{"name":5,"class":6},40]