Disorders of Excessive Somnolence clinical trials

Every programme with a company-led study here in the last two years, whatever its size: 9 programmes from 6 companies, 2 with this as their studies’ main aim; 6 with a live phase 3 study; 7 primary completions in the next 12 months.

Comparator & background therapies

What other companies’ phase 2+ studies give as the comparator or the background here (its leading trial sponsor and partners left out): a sign of what new drugs are measured against, not by itself the standard of care, its prescriptions or its market.

None given by two companies or more yet.

Programmes

“Meets, by arms” reads each study’s arms: vs its arm against the therapy’s; + X vs a combination against it; added to it plus the therapy against the therapy; studied with given together only. The next primary completion is the next phase-3 study’s when there is one.

The 1 in phase 3 with the nearest primary completion, of 9 programmes — sign in to see the whole list, free: filter by phase and aim, sort by late development, direct comparisons or the next primary completion.

Primary completion in the next 12 months (7)

Live phase 2 and 3 studies of these programmes. Primary completion is when the main measure’s data collection ends, as the registry states it (most are estimates); results come later, if they are announced.

• Nov 2026 est.alixorexton · Alkermes, Inc. · Phase 2 named, not the main aimNCT06843590 A Study to Evaluate the Safety and Effectiveness of ALKS 2680 in Subjects With Idiopathic Hypersomnia — primary endpoint: Change in Epworth Sleepiness Scale (ESS) from baseline to Week 8 by dose level · 126 enrolled
• Dec 2026 est.solriamfetol · Axsome Therapeutics, Inc. · Phase 3 main aimNCT06568367 Studying Solriamfetol Modulation of TAAR-1, Dopamine, and Norepinephrine in Shift Work Disorder (SUSTAIN) — primary endpoint: Change from Baseline to Week 12 in the mean sleep latency time as measured by the Maintenance of Wakefulness Test (MWT). · 520 enrolled
• May 2027 est.alixorexton · Alkermes, Inc. · Phase 3 named, not the main aimNCT07502443 A Study to Evaluate the Efficacy and Safety of ALKS 2680 in Adults With Narcolepsy Type 2 — primary endpoint: Change in mean sleep latency (MSL) on Maintenance of Wakefulness Test (MWT) from baseline to Week 12 by dose level · 176 enrolled

4 more — sign in to see them all, free.

Read from ClinicalTrials.gov, industry-led studies. Main aim: this is the study’s judged main condition; named, not the main aim: the sponsor names it, the study is about something else; registry mapping only: only the registry’s mapping put it here. Leading trial sponsor is the company leading the most industry studies of a drug, a measure of trial activity, not of rights. US and EU rights, and Approved: from the regulators’ records (FDA’s Drugs@FDA via openFDA; EMA’s medicines data) — the holder of a marketed or authorised original, generics and other companies’ versions; not rights elsewhere, nor approval for this condition. Phase 4 trial recorded, where neither lists it: a phase 4 study exists somewhere. Not read yet: labels by indication, exclusivity, licences, line of therapy, academic comparators, sales.