25 completed, 4 recruiting, 1 active not recruiting, 1 terminated. 15 Phase 3, 8 Phase 2, 3 Not applicable, 1 Phase 1, 1 Phase 4.
| Phase | Trials | Status |
|---|---|---|
| Phase 3 | 15 | Completed 14, Withdrawn 1 |
| Phase 2 | 8 | Completed 7, Terminated 1 |
| Not applicable | 3 | Active not recruiting 1, Completed 1, Recruiting 1 |
| Phase 1 | 1 | Recruiting 1 |
| Phase 4 | 1 | Completed 1 |
Follow Excessive Daytime Sleepiness: new trials by email Literature Review of Excessive Daytime Sleepiness trials Research Report on Excessive Daytime Sleepiness
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 |
|---|---|---|---|---|---|---|
| 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 | |
| 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 |
| Validating a Novel Driving Simulation-based MWT Against the Standard MWT in an OSA-cohort Challenged by CPAP-withdrawal CPAP-withdrawal, Test Sequence - Excessive Daytime Sleepiness, Obstructive Sleep Apnea (OSA) | Not applicable | Recruiting | Stefan Lakämper | 54 | 2025-07-14 | 2025-07-17 |
| A Study of ORX142 in Healthy Adult Subjects, Including Subjects 18 to 80 Years of Age ORX142 Tablets, Placebo Tablets - Excessive Daytime Sleepiness | Phase 1 | Recruiting | Centessa Pharmaceuticals (UK) Limited | 208 | 2025-06-30 | 2025-12-24 |
| SLEEPINESS - a Search for a Biomarker of Excessive Daytime Sleepiness in Severe Obstructive Sleep Apnoea - An Explorative Study continuous positive airway pressure - Obstructive Sleep Apnea (OSA), Excessive Daytime Sleepiness | Recruiting | Zealand University Hospital | 15 | 2024-10-11 | 2024-12-02 | |
| Characterization of Children with Complaints of Excessive Daytime Sleepiness Assessment of socio-demographic, anthropometric, psychometric and clinical characteristics - Excessive Daytime Sleepiness | Completed | Hospices Civils de Lyon | 400 | 2024-01-01 | 2025-03-27 | |
| Impact of Bright Light Therapy on Prader-Willi Syndrome Sham Light, Bright Light Therapy - Prader-Willi Syndrome, Excessive Daytime Sleepiness | Not applicable | Active not recruiting | Maimonides Medical Center | 50 | 2023-10-01 | 2026-10-06 |
| A Twelve-week, Double-blind, Placebo-controlled, Randomized, Parallel-group, Multicenter Study to Evaluate the Efficacy and Safety of Solriamfetol in the Treatment of Excessive Daytime Sleepiness (EDS) in Patients with Obstructive Sleep Apnea (OSA) Solriamfetol, Placebo - Sleep Apnea, Obstructive, Excessive Daytime Sleepiness | Phase 3 | Completed | Ignis Therapeutics (Suzhou) Limited | 204 | 2023-08-01 | 2025-03-03 |
| Alternative Epworth Sleepiness Scale ESS-ALT in French Test of an alternative Epworth Sleepiness Scale ESS-ALT in French - Excessive Daytime Sleepiness | Completed | Assistance Publique - Hôpitaux de Paris | 102 | 2023-06-28 | 2023-11-27 | |
| A Long-Term Safety and Effectiveness Study to Evaluate Pitolisant in Adult Patients With Idiopathic Hypersomnia Pitolisant - Idiopathic Hypersomnia, Excessive Daytime Sleepiness | Phase 3 | Completed | Harmony Biosciences Management, Inc. | 119 | 2022-08-19 | 2025-12-12 |
| A Clinical Study to Evaluate the Efficacy and Safety of Pitolisant in the Treatment of EDS in Patients With OSA Pitolisant, Placebo oral tablet - Excessive Daytime Sleepiness | Phase 3 | Completed | Citrine Medicine Limited | 240 | 2022-04-12 | 2023-07-20 |
| A Study to Assess the Long-term Efficacy and Safety of AXS-12 (Reboxetine) in Subjects With Narcolepsy (ENCORE) AXS-12 (reboxetine), Placebo - Narcolepsy, Cataplexy | Phase 3 | Completed | Axsome Therapeutics, Inc. | 68 | 2021-10-20 | 2025-11-13 |
| A Study to Assess the Efficacy and Safety of AXS-12 (Reboxetine) in Patients With Narcolepsy AXS-12 (reboxetine), Placebo - Narcolepsy, Cataplexy | Phase 3 | Completed | Axsome Therapeutics, Inc. | 90 | 2021-09-15 | 2026-05-28 |
| Four-week Study of the Safety and Efficacy of NLS-2 (Mazindol Extended Release) in the Treatment of Narcolepsy mazindol extended release, Placebo - Narcolepsy, Excessive Daytime Sleepiness | Phase 2 | Completed | NLS Pharmaceutics | 67 | 2021-09-13 | 2022-08-12 |
| Safety and Efficacy of Pitolisant on Excessive Daytime Sleepiness and Other Non-Muscular Symptoms in Patients With Myotonic Dystrophy Type 1 Pitolisant Oral Tablet, Placebo oral tablet - Myotonic Dystrophy 1, Excessive Daytime Sleepiness | Phase 2 | Completed | Harmony Biosciences Management, Inc. | 30 | 2021-06-28 | 2026-09-04 |
| Solriamfetol's Effect on Cognitive Health in Apnea Participants During a Randomized Placebo-controlled Study Solriamfetol, Placebo - Excessive Daytime Sleepiness, Obstructive Sleep Apnea | Phase 4 | Completed | Axsome Therapeutics, Inc. | 59 | 2021-05-17 | 2026-01-26 |
| BEN-2001 in Parkinson Disease Patients With Excessive Daytime Sleepiness BEN-2001, Placebo - Excessive Daytime Sleepiness, Parkinson Disease | Phase 2 | Completed | BenevolentAI Bio | 244 | 2017-11-10 | 2025-03-10 |
| Once-Nightly Sodium Oxybate for Treatment of Excessive Daytime Sleepiness and Cataplexy in Narcolepsy FT218, Placebo - Excessive Daytime Sleepiness, Cataplexy | Phase 3 | Completed | Avadel | 212 | 2016-11-17 | 2022-03-22 |
| Pitolisant (BF2.649) in the Treatment of EDS in Patients With OSA Pitolisant (BF2.649), Placebo - Excessive Daytime Sleepiness, Obstructive Sleep Apnea | Phase 3 | Completed | Bioprojet | 389 | 2016-04-01 | 2020-07-08 |
| Pitolisant to Assess Weekly Frequency of Cataplexy Attacks and EDS in Narcoleptic Patients (HARMONY CTP) Pitolisant, Placebo - Narcolepsy With Cataplexy, Excessive Daytime Sleepiness | Phase 3 | Completed | Bioprojet | 103 | 2013-04-01 | 2016-08-31 |
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Disorders of Excessive Somnolence (32) · Sleep Apnea, Obstructive (13) · Narcolepsy (10) · Cataplexy (6) · Sleep Wake Disorders (5) · Parkinson Disease (2) · Behavior (1) · Body Weight (1) · Depression (1) · Depressive Disorder, Major (1) · Hyperphagia (1) · Idiopathic Hypersomnia (1) · Motor Activity (1) · Myotonic Dystrophy (1) · Prader-Willi Syndrome (1)
Dyssomnias (32) · Mental Disorders (32) · Nervous System Diseases (32) · Sleep Disorders, Intrinsic (32) · Sleep Wake Disorders (27) · Apnea (13) · Respiration Disorders (13) · Respiratory Tract Diseases (13) · Sleep Apnea Syndromes (12) · Pathological Conditions, Signs and Symptoms (7) · Signs and Symptoms (7) · Neurologic Manifestations (6) · Brain Diseases (3) · Central Nervous System Diseases (3) · Neurodegenerative Diseases (3)
pitolisant (12) · Modafinil (3) · Reboxetine (2) · solriamfetol (2) · Continuous Positive Airway Pressure (1) · N-ethyl-3-fluoro-3-(3-fluoro-4-(pyrrolidinylmethyl)phenyl)cyclobutanecarboxamide (1) · Psychometrics (1) · Ultraviolet Therapy (1) · bavisant (1)
Bioprojet (9) · Axsome Therapeutics, Inc. (3) · Cephalon (2) · Harmony Biosciences Management, Inc. (2) · Assistance Publique - Hôpitaux de Paris (1) · Avadel (1) · BenevolentAI Bio (1) · Centessa Pharmaceuticals (UK) Limited (1) · Citrine Medicine Limited (1) · Hospices Civils de Lyon (1) · Ignis Therapeutics (Suzhou) Limited (1) · Kuwait University (1) · Maimonides Medical Center (1) · Malin Eleonora av Kák Gustafsson, MD, PhD (1) · Merck Sharp & Dohme LLC (1)
United States (13) · France (9) · Canada (7) · Switzerland (3) · Australia (2) · China (2) · Germany (2) · Bulgaria (1) · Czechia (1) · Denmark (1) · Hungary (1) · Italy (1) · Kuwait (1) · Netherlands (1) · North Macedonia (1)
Evelyne De Paillette, MD (3) · Claudio Bassetti (2) · Carlos Camozzi, MD (1) · Carsten Moeller (1) · Colin M. Shapiro, MBBCh, PhD (1) · Dr. Maryam Alemairi, PT, PhD (1) · Edward Yi, MD (1) · Esther I Schwarz, PD, Dr. med. (1) · Evelyne De Paillette, Dr (1) · Kristina Keller, Dr. med. (1) · Sharon A. Chung, PhD (1)
PMID 34822113, PMID 34935103, PMID 37979718, PMID 16491981, PMID 19192466, PMID 23920422, PMID 24107292, PMID 28129985, PMID 31917607, PMID 33121980, PMID 34358324, PMID 35380374, PMID 36790141, PMID 39153911, PMID 39321628, PMID 39528111, PMID 40111738, PMID 40111739, PMID 40851446, PMID 41128833, PMID 42424269
2008 (2), 2009 (1), 2016 (1), 2025 (1)