14 completed, 1 withdrawn. 15 Phase 3.
| Phase | Trials | Status |
|---|---|---|
| Phase 3 | 15 | Completed 14, Withdrawn 1 |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 |
|---|---|---|---|---|---|---|
| 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 |
| 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 |
| 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 |
| BF2.649 in Patients With OSA, Still Complaining of EDS and Refusing to be Treated by CPAP. BF2.649, Placebo - Obstructive Sleep Apnea, Excessive Daytime Sleepiness | Phase 3 | Completed | Bioprojet | 268 | 2011-10-01 | 2015-01-21 |
| BF2.649 in Patients With OSA and Treated by CPAP But Still Complaining of EDS BF2.649, Placebo - Obstructive Sleep Apnea, Excessive Daytime Sleepiness | Phase 3 | Completed | Bioprojet | 244 | 2011-08-01 | 2015-01-21 |
| Efficacy and Safety Study of BF2.649 and BF2.649 Add on Modafinil on Cataplexy in Patients With Narcolespy BF2.649, BF2.649 add on Modafinil - Narcolepsy, Cataplexy | Phase 3 | Completed | Bioprojet | 14 | 2009-10-01 | 2013-02-11 |
| Efficacy and Safety Study of BF2.649 in the Treatment of Excessive Daytime Sleepiness in Narcolepsy BF2.649, Modafinil, Placebo - Narcolepsy, Excessive Daytime Sleepiness | Phase 3 | Completed | Bioprojet | 110 | 2009-05-01 | 2012-06-11 |
| Study to Assess Patient Reported Outcomes With Armodafinil Treatment for Excessive Sleepiness in Adults With Narcolepsy or Obstructive Sleep Apnea/Hypopnea Syndrome Armodafinil - Excessive Daytime Sleepiness, Narcolepsy | Phase 3 | Completed | Cephalon | 247 | 2005-10-01 | 2013-07-19 |
| Extension Study of the Safety and Efficacy of Armodafinil in the Treatment of Patients With Excessive Sleepiness Armodafinil 100 to 250 mg/day - Excessive Daytime Sleepiness, Narcolepsy | Phase 3 | Completed | Cephalon | 743 | 2004-05-01 | 2013-07-19 |
| Pitolisant (BF2.649) in the Treatment of Excessive Daytime Sleepiness in Patients With Obstructive Sleep Apnoea Syndrome, Treated or Not by Nasal Continuous Positive Airway Pressure, But Still Complaining of Excessive Daytime Sleepiness Pitolisant (BF2.649), Placebo Oral Tablet - Excessive Daytime Sleepiness, Obstructive Sleep Apnea | Phase 3 | Withdrawn | Bioprojet | 2017-11-24 |
Disorders of Excessive Somnolence (15) · Narcolepsy (8) · Sleep Apnea, Obstructive (7) · Cataplexy (6) · Sleep Wake Disorders (4) · Idiopathic Hypersomnia (1) · Sleepiness (1)
Dyssomnias (15) · Mental Disorders (15) · Nervous System Diseases (15) · Sleep Disorders, Intrinsic (15) · Sleep Wake Disorders (11) · Apnea (7) · Respiration Disorders (7) · Respiratory Tract Diseases (7) · Sleep Apnea Syndromes (7) · Pathological Conditions, Signs and Symptoms (5) · Signs and Symptoms (5) · Neurologic Manifestations (4)
pitolisant (9) · Modafinil (3) · Reboxetine (2) · solriamfetol (1)
Bioprojet (7) · Axsome Therapeutics, Inc. (2) · Cephalon (2) · Avadel (1) · Citrine Medicine Limited (1) · Harmony Biosciences Management, Inc. (1) · Ignis Therapeutics (Suzhou) Limited (1)
United States (6) · France (5) · Canada (4) · Australia (2) · China (2) · Germany (2) · Switzerland (2) · Bulgaria (1) · Czechia (1) · Hungary (1) · North Macedonia (1) · Puerto Rico (1) · Russia (1)
Claudio Bassetti (2) · Evelyne De Paillette, MD (2) · Evelyne De Paillette, Dr (1)
PMID 34822113, PMID 34935103, PMID 37979718, PMID 24107292, PMID 28129985, PMID 31917607, PMID 33121980, PMID 34358324, PMID 35380374, PMID 39153911, PMID 39321628, PMID 40111738, PMID 40111739, PMID 40851446, PMID 41128833
2008 (2), 2009 (1), 2016 (1)