Disorders of Excessive Somnolence clinical trials
The registry lists 196 studies for Disorders of Excessive Somnolence across more than 10 countries. 34 are recruiting or about to start. 42 of them are mainly about Disorders of Excessive Somnolence (how this is decided). Per ClinicalTrials.gov, last updated 2026-11-13. Counting its 3 narrower conditions too, such as Narcolepsy: 334 studies, 73 open.
Get an email when these change. Save the Disorders of Excessive Somnolence studies recruiting or about to start — once a week, free: studies that open, close, add sites or post results.
See an example email
Example · made-up studies
Breast cancer · Recruiting: 2 came in, 3 changed
What changed in your saved searches, Oct 31 – Nov 6:
A study of drug A after surgery for early breast cancer
Came in · now Recruiting
Drug B with hormone therapy in advanced breast cancer
Changed
· Sites: 4 added, including Seoul and Busan
· Enrollment: 300 → 450 participants
Exercise during chemotherapy
Now Active, not recruiting
One email a week for all your saved searches. Stop any time.
Who runs them
Cephalon (13) · Bioprojet (12) · Alkermes, Inc. (7) · Axsome Therapeutics, Inc. (7) · Jazz Pharmaceuticals (5) · Northwestern University (4) · Harmony Biosciences Management, Inc. (4) · Hospices Civils de Lyon (4)
Who develops what
Save this setEvery 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.
| In phase 3 | Company |
|---|---|
| solriamfetolApproved: US 2019 · EU 20202 live phase-3 studies: NCT07484217, NCT06568367 | Axsome Therapeutics, Inc. |
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.
What is being tested here
Drugs under test in Disorders of Excessive Somnolence studies, those with the most open studies first. Medicines only given beside them are not counted. How drugs are counted
| Drug | Open | Phase 3 | All |
|---|---|---|---|
| Solriamfetol | 3 | 3 | 12 |
| Pitolisant | 1 | 13 | 16 |
| Alixorexton | 1 | 1 | 3 |
| Samelisant | 1 | 1 | 2 |
| HBS-301 | 1 | 1 | 1 |
| Berobenatide | 1 | 1 | 1 |
| Modafinil | 0 | 12 | 22 |
| Sodium Oxybate | 0 | 2 | 5 |
| Oxybate | 0 | 2 | 5 |
| Reboxetine | 0 | 2 | 3 |
Drug classes tested here Stimulants 24
Coming up
Studies recruiting or running, from their records. “Main data collection” ends at the primary completion date, the sponsor’s own estimate, which often moves.
The 10 nearest, phase 3 first
- Dec 2026Studying Solriamfetol Modulation of TAAR-1, Dopamine, and Norepinephrine in Shift Work Disorder (SUSTAIN) · Phase 3 · Axsome Therapeutics, Inc.
- Apr 2027A Study of Pitolisant in Patients With Prader-Willi Syndrome · Phase 3 · Harmony Biosciences Management, Inc.
- May 2027A Study to Evaluate the Efficacy and Safety of ALKS 2680 in Adults With Narcolepsy Type 2 · Phase 3 · Alkermes, Inc.
- May 2027A Study to Evaluate the Efficacy and Safety of ALKS 2680 in Adults With Narcolepsy Type 1 · Phase 3 · Alkermes, Inc.
- Jun 2027A Study to Evaluate the Efficacy, Safety and Tolerability of ALKS 2680 in Adults With Narcolepsy Type 1 (Brilliance NT1 - 304) · Phase 3 · Alkermes, Inc.
- Sep 2027A Study to Investigate the Effects of Cleminorexton Compared With Placebo in the Treatment of Participants With Central Disorders of Hypersomnolence · Phase 3 · Centessa Pharmaceuticals (UK) Limited
- Oct 2027A Phase 3 Efficacy and Safety Study of HBS-301 in Participants With Idiopathic Hypersomnia (IH) · Phase 3 · Harmony Biosciences Management, Inc.
- Nov 2027A Phase 3 Study to Evaluate the Efficacy and Safety of Samelisant in Patients With Narcolepsy (AWAKE) · Phase 3 · Suven Life Sciences Limited
- Nov 2026A Study to Evaluate the Safety and Effectiveness of ALKS 2680 in Subjects With Idiopathic Hypersomnia · Alkermes, Inc.
- Dec 2026Solriamfetol for the Treatment of Multiple Sclerosis Fatigue · Johns Hopkins University
Who these studies take
Of the 30 Disorders of Excessive Somnolence studies recruiting now, 12 (40%) set no upper age limit and 17 (57%) stop at 75 or younger. 5 (17%) take children under 18. 0 (0%) are for women only and 0 (0%) for men only; 7 (23%) take healthy volunteers.
| Age | Women | Men |
|---|---|---|
| 10 | 4 (13%) | 4 (13%) |
| 18 | 30 (100%) | 30 (100%) |
| 30 | 28 (93%) | 28 (93%) |
| 40 | 28 (93%) | 28 (93%) |
| 50 | 27 (90%) | 27 (90%) |
| 65 | 25 (83%) | 25 (83%) |
| 75 | 13 (43%) | 13 (43%) |
| 85 | 12 (40%) | 12 (40%) |
Across all 196 studies, recruiting or not: 52% stop at 75 or younger and 39% at 65; 16% take children; 1% are for women only and 3% for men only; 24% take healthy volunteers. From each study’s registry entry; the criteria on its page decide.
How long Disorders of Excessive Somnolence studies take
Of 15 phase 2 interventional studies under Disorders of Excessive Somnolence, half reached primary completion within 19 months of starting, counting those still running.
| Start to primary completion | Every sponsor | Industry | Non-industry |
|---|---|---|---|
| Phase 2 | 19 mo15–34 · 15 studies | — | — |
| Interventional, no phase | 22 mo7–35 · 34 studies | — | 22 mo9–35 · 32 studies |
Each figure is the month by which half the studies had reached primary completion, with the range in which the middle half did. Studies still running count until their last registry update; studies that stopped early are left out. Phase 1 includes early phase 1; observational means prospective or not stated, as retrospective and cross-sectional studies date a window of data rather than a study. How these figures are worked out
What changed recently
From the registry's own updates since Oct 15, 2026.
Started recruiting1
Results posted1
Newly registered5
- Evolution of the Treatment of Rare Hypersomnias in a Reference Center Certified Since 2005Nov 12, 2026NCT07930728
- A Study to Evaluate the Safety and Efficacy of ALKS 7290 as an Adjunctive Therapy to Antidepressants in Adult Participants With Major Depressive DisorderOct 28, 2026NCT07901179
- Feasibility and Acceptability of a 6-Week Myofunctional and Physical Activity Program for University Students With Excessive Daytime SleepinessOct 19, 2026NCT07879859
- Sleep Quality and Frailty Among People Living With HIVOct 19, 2026NCT07880054
- A Study to Learn About the Monthly Dosing Study Medicine Called Berobenatide in Adults With Breathing Problems During Sleep and Overweight or Obesity Who Do Not Use a Breathing Machine (PAP) (VESPER-OSA 2)Oct 19, 2026NCT07881757
Studies
Recruiting first, then most recently updated. Showing 50 of 196. Browse all 196 → or search them.
- A Phase 3 Efficacy and Safety Study of HBS-301 in Participants With Idiopathic Hypersomnia (IH)RecruitingNCT07500090Phase 32 countries
- Evolution of the Treatment of Rare Hypersomnias in a Reference Center Certified Since 2005Not yet recruitingNCT079307281 country
- A Study to Learn About the Monthly Dosing Study Medicine Called Berobenatide in Adults With Breathing Problems During Sleep and Overweight or Obesity Who Do Not Use a Breathing Machine (PAP) (VESPER-OSA 2)RecruitingNCT07881757Phase 31 country
- A Study to Investigate the Effects of Cleminorexton Compared With Placebo in the Treatment of Participants With Central Disorders of HypersomnolenceRecruitingNCT07598708Phase 2/31 country
- Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at SanfordRecruitingNCT017931681 country
- A Study to Evaluate the Safety and Efficacy of ALKS 7290 as an Adjunctive Therapy to Antidepressants in Adult Participants With Major Depressive DisorderRecruitingNCT07901179Phase 21 country
- Clinical Assessment of Response in the Treatment of Depression With Daytime Sleepiness Using SolriamfetolRecruitingNCT07484217Phase 31 country
- A Long-Term Study of ALKS 2680 in Subjects With Narcolepsy and Idiopathic HypersomniaRecruitingNCT06767683Phase 2/38 countries
- A Study to Evaluate the Efficacy and Safety of ALKS 2680 in Adults With Narcolepsy Type 2RecruitingNCT07502443Phase 310 countries
- A Study to Evaluate the Efficacy and Safety of ALKS 2680 in Adults With Narcolepsy Type 1RecruitingNCT07455383Phase 310 countries
- A Study to Evaluate the Efficacy, Safety and Tolerability of ALKS 2680 in Adults With Narcolepsy Type 1 (Brilliance NT1 - 304)RecruitingNCT07540897Phase 35 countries
- Sleep and Stroke Rehabilitation StudyRecruitingNCT075798711 country
- A Phase 3 Study to Evaluate the Efficacy and Safety of Samelisant in Patients With Narcolepsy (AWAKE)RecruitingNCT07540364Phase 31 country
- A Study of Pitolisant in Patients With Prader-Willi SyndromeRecruitingNCT06366464Phase 313 countries
- a Chronobiological Treatment Combining Evening Melatonin and Morning Light Therapy in Idiopathic Hypersomnia: a Prospective, Double Bind, Randomized, Placebo-controlled -TrialRecruitingNCT06252571Phase 21 country
- Studying Solriamfetol Modulation of TAAR-1, Dopamine, and Norepinephrine in Shift Work Disorder (SUSTAIN)RecruitingNCT06568367Phase 32 countries
- Morning Bright Light Therapy and Daytime Functioning in University StudentsRecruitingNCT07685262Not applicable1 country
- Solriamfetol for the Treatment of Multiple Sclerosis FatigueRecruitingNCT06170970Phase 21 country
- A Long-term Extension Study of ORX750 in Participants With Narcolepsy and Idiopathic HypersomniaRecruitingNCT07096674Phase 24 countries
- Daytime vs Evening Rehabilitation in Lumbar Disc Herniation Patients at High Risk for Obstructive Sleep ApneaNot yet recruitingNCT07522021Not applicable
- Test-retest Reliability of the Maintenance of Wakefulness Test in Participants With HypersomnolenceRecruitingNCT07120061Not applicable1 country
- Promoting Teenage Sleep for Improved Mental Health and School PerformanceRecruitingNCT06306092Not applicable1 country
- A Study of ORX142 in Healthy Adult Subjects, Including Subjects 18 to 80 Years of AgeRecruitingNCT07082829Phase 11 country
- A Study Assessing Adult Patients Referred to an NHS Sleep Service With Suspected Obstructive Sleep Apnoea. This Study Aims to Compare the Sunrise Wearable Diagnostic Device Performance and Potential Inclusion in a NHS Diagnostic Pathway With Oximetry and WatchPAT Which Are Currently Used.RecruitingNCT07269483Not applicable1 country
- Adult Sleep Health in the Rural Appalachia and Mississippi Delta Region and Its Relationships With Cardiometabolic Health Disparities.Enrolling by invitationNCT063365251 country
- A Novel Approach to Manage Symptoms of Narcolepsy and Idiopathic HypersomniaRecruitingNCT07006233Not applicable1 country
- Validating a Novel Driving Simulation-based MWT Against the Standard MWT in an OSA-cohort Challenged by CPAP-withdrawalRecruitingNCT06872593Not applicable1 country
- Digital Sleep Program for College Students with InsomniaRecruitingNCT06853106Not applicable1 country
- Mind-wandering and Predictive Processes in Narcolepsy: a Putative Mechanism Through Covert REM IntrusionsRecruitingNCT06457945Not applicable1 country
- SLEEPINESS - a Search for a Biomarker of Excessive Daytime Sleepiness in Severe Obstructive Sleep Apnoea - An Explorative StudyRecruitingNCT067111591 country
- Constitution of a Clinical, Neurophysiological and Biological Cohort for Chronic Sleep Disorders Responsible of HypersomnolenceRecruitingNCT03998020Not applicable1 country
- A Pilot Observational Study to Assess the Ability of Continuous 'Home' EEG to Accurately Diagnose Narcolepsy and Demonstrate Response to TreatmentNot yet recruitingNCT05983731
- Treating Comorbid Depression of Patients With Narcolepsy by Intermittent Theta Burst StimulationRecruitingNCT05884112Not applicable1 country
- International Swiss Primary Hypersomnolence and Narcolepsy Cohort StudyRecruitingNCT043309631 country
- A Long-Term Safety and Effectiveness Study to Evaluate Pitolisant in Adult Patients With Idiopathic HypersomniaCompletedNCT05458128Phase 31 country
- Sleep Quality and Frailty Among People Living With HIVCompletedNCT078800541 country
- Feasibility and Acceptability of a 6-Week Myofunctional and Physical Activity Program for University Students With Excessive Daytime SleepinessCompletedNCT07879859Not applicable1 country
- Impact of Bright Light Therapy on Prader-Willi SyndromeActive, not recruitingNCT05939453Not applicable1 country
- A Study to Evaluate the Safety and Effectiveness of ALKS 2680 in Subjects With Idiopathic HypersomniaActive, not recruitingNCT06843590Phase 28 countries
- Bonafide Sleep Supplement for Menopausal Women With Sleep ComplaintsCompletedNCT07839312Not applicable1 country
- Sleep and Morning Wellbeing StudyCompletedNCT07311434Not applicable1 country
- Safety and Efficacy of Pitolisant on Excessive Daytime Sleepiness and Other Non-Muscular Symptoms in Patients With Myotonic Dystrophy Type 1CompletedNCT04886518Phase 22 countries
- A Study to Investigate the Effect of XYWAV on Sleepiness, Polysomnography, and Functional Outcomes in Participants With Idiopathic Hypersomnia or NarcolepsyCompletedNCT05875974Phase 42 countries
- Disentangling the Role of Depression in HypersomniaCompletedNCT058506761 country
- Whole Food Plant-based Diet Effect on Obstructive Sleep ApneaTerminatedNCT06395181Not applicable1 country
- Radar Sleep Monitoring in Type 1 Narcolepsy: FeasibilityActive, not recruitingNCT076548031 country
- Validating the Use of a Subjectively Reported Sleep Vital SignCompletedNCT03018912Not applicable1 country
- Study of SDX in Patients With Idiopathic Hypersomnia (IH)CompletedNCT05668754Phase 21 country
- Clinical Outcomes in Narcolepsy and Cataplexy: An Evaluation of Reboxetine Treatment (CONCERT)CompletedNCT03881852Phase 21 country
- RECOVER-SLEEP: Platform Protocol, Appendix_A (Hypersomnia)CompletedNCT06404099Phase 21 country