198 completed, 47 recruiting, 25 unknown, 15 terminated. 96 Not applicable, 66 Phase 3, 55 Phase 2, 24 Phase 1, 19 Phase 4.
Follow Disorders of Excessive Somnolence: new trials by email Literature Review of Disorders of Excessive Somnolence trials Research Report on Disorders of Excessive Somnolence
Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| 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) Berobenatide, Placebo - Apnea, Sleep Disorders | Phase 3 | Not yet recruiting | Pfizer | 258 | 2026-10-19 | 2026-10-19 |
| Hypersomnia in the Paediatric Population Sleepness and wakeness scale, Polysomnography, Actimetry - Wakefulness Disorder, Narcolepsy | Not applicable | Not yet recruiting | University Hospital, Montpellier | 760 | 2026-09-01 | 2026-08-14 |
| A Phase 3 Study to Evaluate the Efficacy and Safety of Samelisant in Patients With Narcolepsy (AWAKE) Samelisant, Placebo - Narcolepsy | Phase 3 | Recruiting | Suven Life Sciences Limited | 240 | 2026-09-01 | 2026-09-03 |
| A Study to Evaluate the Efficacy, Safety and Tolerability of ALKS 2680 in Adults With Narcolepsy Type 1 (Brilliance NT1 - 304) ALKS 2680 Dose 1, ALKS 2680 Dose 2, Placebo - Narcolepsy Type 1 | Phase 3 | Recruiting | Alkermes, Inc. | 150 | 2026-08-13 | 2026-10-07 |
| A Study Evaluating the Efficacy and Safety of Xywav Expanded Dosing vs Placebo in Participants With Narcolepsy or IH Xywav, Placebo - Narcolepsy, Idiopathic Hypersomnia | Phase 3 | Recruiting | Jazz Pharmaceuticals | 120 | 2026-07-09 | 2026-10-08 |
| Decreasing Nightmares in Adults With Narcolepsy Imagery Rehearsal Therapy (IRT) - Narcolepsy, Narcolepsy Type 1 | Not applicable | Recruiting | University of Utah | 80 | 2026-07-01 | 2026-07-15 |
| A Study of TAK-360 in People With Narcolepsy or Idiopathic Hypersomnia TAK-360, Placebo - Idiopathic Hypersomnia, Narcolepsy Type 1 | Phase 2 / Phase 3 | Recruiting | Takeda | 500 | 2026-06-11 | 2026-09-18 |
| A Study of TAK-360 in Adults With Narcolepsy Type 1 (Narcolepsy With Cataplexy) TAK-360, Placebo - Narcolepsy Type 1 | Phase 2 | Recruiting | Takeda | 92 | 2026-06-04 | 2026-06-29 |
| A Phase 3 Efficacy and Safety Study of HBS-301 in Participants With Narcolepsy HBS-301, Placebo - EDS, Cataplexy | Phase 3 | Recruiting | Harmony Biosciences Management, Inc. | 258 | 2026-06-04 | 2026-08-27 |
| A Study to Investigate the Effects of Cleminorexton Compared With Placebo in the Treatment of Participants With Central Disorders of Hypersomnolence cleminorexton, Placebo - Narcolepsy Type 1, Narcolepsy Type 2 | Phase 2 / Phase 3 | Recruiting | Centessa Pharmaceuticals (UK) Limited | 222 | 2026-05-29 | 2026-10-02 |
| Radar Sleep Monitoring in Type 1 Narcolepsy: Feasibility Narcolepsy Type 1 (NT 1), Hypersomnolence Disorder | Active not recruiting | Xijing Hospital | 1 | 2026-05-07 | 2026-07-21 | |
| Effects of Operational Naps on Blood Pressure and Performance Among Night Shift Workers No-nap, 15-min nap, 30-min nap - Shift Work | Not applicable | Recruiting | University of Pittsburgh | 130 | 2026-05-07 | 2026-06-03 |
| A Study to Evaluate the Efficacy and Safety of ALKS 2680 in Adults With Narcolepsy Type 2 ALKS 2680 Dose 1, ALKS 2680 Dose 2, ALKS 2680 Dose 3 - Narcolepsy Type 2 | Phase 3 | Recruiting | Alkermes, Inc. | 176 | 2026-04-22 | 2026-10-07 |
| Daytime vs Evening Rehabilitation in Lumbar Disc Herniation Patients at High Risk for Obstructive Sleep Apnea Physiotherapy and Exercise Program - Lumbar Disc Herniation, Obstructive Sleep Apnea Risk Management | Not applicable | Not yet recruiting | Mardin Artuklu University | 60 | 2026-04-10 | 2026-04-13 |
| A Study to Evaluate the Efficacy and Safety of ALKS 2680 in Adults With Narcolepsy Type 1 ALKS 2680 Dose 1, ALKS 2680 Dose 2, Placebo - Narcolepsy Type 1 | Phase 3 | Recruiting | Alkermes, Inc. | 150 | 2026-04-06 | 2026-10-07 |
| A Study to Evaluate the Efficacy and Safety of E2086 in Adults With Narcolepsy E2086, Placebo - Narcolepsy | Phase 2 | Recruiting | Eisai Inc. | 64 | 2026-03-26 | 2026-05-14 |
| Sleep and Stroke Rehabilitation Study Stroke, Sleep Apnea Syndrome (OSAS) | Recruiting | Malin Eleonora av Kák Gustafsson, MD, PhD | 226 | 2026-03-18 | 2026-09-24 | |
| A Phase 3 Efficacy and Safety Study of HBS-301 in Participants With Idiopathic Hypersomnia (IH) HBS-301 tablet, Placebo - Idiopathic Hypersomnia | Phase 3 | Recruiting | Harmony Biosciences Management, Inc. | 248 | 2026-03-16 | 2026-09-14 |
| Clinical Assessment of Response in the Treatment of Depression With Daytime Sleepiness Using Solriamfetol Solriamfetol 150 MG, Placebo - Major Depressive Disorder With Excessive Daytime Sleepiness Symptoms | Phase 3 | Recruiting | Axsome Therapeutics, Inc. | 508 | 2026-02-23 | 2026-10-13 |
| Feasibility and Acceptability of a 6-Week Myofunctional and Physical Activity Program for University Students With Excessive Daytime Sleepiness MYOPAP Program - Excessive Daytime Sleepiness, Disorders of Excessive Somnolence | Not applicable | Completed | Kuwait University | 14 | 2026-02-15 | 2026-10-19 |
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Narcolepsy (137) · Idiopathic Hypersomnia (52) · Sleep Apnea, Obstructive (45) · Sleep Initiation and Maintenance Disorders (34) · Sleep Wake Disorders (32) · Cataplexy (30) · Sleep Apnea Syndromes (21) · Parkinson Disease (18) · Fatigue (16) · Sleep Disorders, Circadian Rhythm (15) · Sleepiness (15) · Parasomnias (13) · Depression (9) · Restless Legs Syndrome (8)
Sleep Disorders, Intrinsic (314) · Dyssomnias (313) · Nervous System Diseases (310) · Mental Disorders (309) · Sleep Wake Disorders (282) · Pathological Conditions, Signs and Symptoms (79) · Signs and Symptoms (68) · Respiratory Tract Diseases (63) · Respiration Disorders (57) · Apnea (53) · Neurologic Manifestations (46) · Sleep Apnea Syndromes (36) · Brain Diseases (35) · Central Nervous System Diseases (35)
Modafinil (35) · pitolisant (20) · solriamfetol (19) · Sodium Oxybate (14) · Continuous Positive Airway Pressure (6) · Surveys and Questionnaires (6) · Ultraviolet Therapy (5) · Polysomnography (4) · Caffeine (3) · Cognitive Behavioral Therapy (3) · Methylphenidate (3) · Reboxetine (3) · samelisant (3) · Blood Specimen Collection (2) · Clarithromycin (2)
Jazz Pharmaceuticals (20) · Cephalon (15) · Bioprojet (14) · Hospices Civils de Lyon (11) · Harmony Biosciences Management, Inc. (9) · Axsome Therapeutics, Inc. (8) · University Hospital, Montpellier (8) · Alkermes, Inc. (7) · Takeda (6) · Northwestern University (5) · Assistance Publique - Hôpitaux de Paris (4) · Avadel (4) · Brigham and Women's Hospital (4) · Centessa Pharmaceuticals (UK) Limited (4) · Emory University (4)
United States (161) · France (67) · Canada (35) · Spain (22) · Italy (20) · Belgium (18) · Switzerland (18) · Germany (16) · Netherlands (16) · Australia (14) · China (11) · Japan (10) · Czechia (9) · Finland (9) · United Kingdom (9)
Evelyne De Paillette, MD (3) · Carlos Camozzi, MD (2) · Chad Ruoff, MD (2) · Christina Barkauskas, MD (2) · Claudio Bassetti (2) · David L Steward, MD (2) · David Seiden, MD (2) · Dennis Hwang, MD (2) · Grace Wang, MD (2) · Jan Ramaekers, PhD (2)
PMID 32356515, PMID 34822113, PMID 34935103, PMID 36494591, PMID 37979718, PMID 10188130, PMID 12531174, PMID 14023898, PMID 16303153, PMID 16473983, PMID 16491981, PMID 16696743, PMID 16872233, PMID 16895262, PMID 17083302, PMID 17552380, PMID 17687131, PMID 17969461, PMID 18678823, PMID 18795985, PMID 19192466, PMID 19238805, PMID 19423426, PMID 19742411, PMID 19880686, PMID 20051221, PMID 20123089, PMID 20181520, PMID 20463578, PMID 20465024, PMID 20530317, PMID 21206549, PMID 22104981, PMID 22178068, PMID 22269988, PMID 22578232, PMID 22734577, PMID 22995695, PMID 23251870, PMID 23920422, PMID 24107292, PMID 24532997, PMID 24587570, PMID 25009530, PMID 25182079, PMID 26030264, PMID 26094838, PMID 26298786, PMID 27166238, PMID 27406645
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