26 completed, 6 recruiting, 1 active not recruiting, 1 unknown. 34 Phase 3, 2 Phase 2.
| Phase | Trials | Status |
|---|---|---|
| Phase 3 | 34 | Completed 26, Recruiting 6, Active not recruiting 1, Unknown 1 |
| Phase 2 | 2 | Recruiting 2 |
Follow Narcolepsy: new trials by email Literature Review of Narcolepsy trials Research Report on Narcolepsy
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 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 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 |
| 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 | 2026-11-03 |
| 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 Trial of TAK-861 for the Treatment of Narcolepsy With Cataplexy TAK-861, Placebo - Narcolepsy Type 1 (NT1), Narcolepsy With Cataplexy | Phase 3 | Active not recruiting | Takeda | 98 | 2026-01-29 | 2026-10-30 |
| A Long-Term Study of ALKS 2680 in Subjects With Narcolepsy and Idiopathic Hypersomnia ALKS 2680, 4mg, ALKS 2680, 6mg, ALKS 2680, 8mg - Narcolepsy Type 1, Narcolepsy Type 2 | Phase 2 / Phase 3 | Recruiting | Alkermes, Inc. | 786 | 2025-01-27 | 2026-10-09 |
| A Eight-Week Study of NLS-2 (Mazindol Extended Release) in Participants With Narcolepsy Type 1 NLS-2, Placebo - Narcolepsy Type 1, Narcolepsy With Cataplexy | Phase 3 | Unknown | NLS Pharmaceutics | 48 | 2024-07-15 | 2024-05-21 |
| 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 |
| An Open Label Study of FT218 in Subjects With Narcolepsy FT218 - Narcolepsy, Cataplexy | Phase 3 | Completed | Avadel | 184 | 2020-06-12 | 2025-10-02 |
| A Study of the Efficacy and Safety of JZP-258 in Subjects With Narcolepsy With Cataplexy JZP-258, Placebo - Narcolepsy With Cataplexy | Phase 3 | Completed | Jazz Pharmaceuticals | 201 | 2017-03-14 | 2020-11-12 |
| 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 |
| Efficacy and Safety of Pitolisant in Pediatric Narcoleptic Patients With or Without Cataplexy, Double-blind Study Followed by a Prolonged Open-label Period pitolisant, Placebo - Narcolepsy With Cataplexy, Narcolepsy Without Cataplexy | Phase 3 | Completed | Bioprojet | 110 | 2016-06-06 | 2025-06-26 |
| "Twelve-week Study of the Safety and Efficacy of JZP-110 in the Treatment of Excessive Sleepiness in Narcolepsy" JZP-110, Placebo oral tablet - Narcolepsy | Phase 3 | Completed | Jazz Pharmaceuticals | 239 | 2015-05-01 | 2019-07-23 |
| "A Long-Term Safety Study of JZP-110 in the Treatment of Excessive Sleepiness in Subjects With Narcolepsy or OSA" JZP-110 - Narcolepsy, Obstructive Sleep Apnea | Phase 3 | Completed | Jazz Pharmaceuticals | 645 | 2015-05-01 | 2019-06-25 |
| A Multicenter Study of the Efficacy and Safety of Xyrem With an Open- Label Pharmacokinetic Evaluation and Safety Extension in Pediatric Subjects With Narcolepsy With Cataplexy Xyrem - Narcolepsy With Cataplexy | Phase 3 | Completed | Jazz Pharmaceuticals | 106 | 2014-10-01 | 2019-04-30 |
| 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 |
| Patient Narcoleptic Treated With BF2.649 (Pitolisant) in add-on to Sodium Oxybate (HARMONY IV) BF2.649 - Narcolepsy | Phase 3 | Completed | Bioprojet | 51 | 2012-09-01 | 2015-11-18 |
| Long Term Open Label Study in Narcolepsy With BF2.649 (Pitolisant) BF2.649 - Narcolepsy, Cataplexy | Phase 3 | Completed | Bioprojet | 102 | 2011-05-01 | 2017-01-31 |
Showing 20 of 34. Sign in to see all of them.
Disorders of Excessive Somnolence (20) · Cataplexy (19) · Sleep Wake Disorders (7) · Sleep Apnea, Obstructive (5) · Fatigue (2) · Idiopathic Hypersomnia (2) · Chronobiology Disorders (1) · Dyssomnias (1) · Hemorrhage (1) · Ischemia (1) · Ischemic Attack, Transient (1) · Mental Disorders (1) · Nervous System Diseases (1) · Parasomnias (1)
Sleep Disorders, Intrinsic (34) · Dyssomnias (33) · Mental Disorders (33) · Nervous System Diseases (33) · Sleep Wake Disorders (27) · Disorders of Excessive Somnolence (14) · Pathological Conditions, Signs and Symptoms (9) · Signs and Symptoms (8) · Neurologic Manifestations (7) · Apnea (5) · Respiration Disorders (5) · Respiratory Tract Diseases (5) · Sleep Apnea Syndromes (4) · Brain Diseases (1) · Brain Ischemia (1)
Modafinil (10) · pitolisant (7) · Sodium Oxybate (5) · Reboxetine (2) · solriamfetol (2) · FANG vaccine (1) · Solutions (1) · disufenton sodium (1) · samelisant (1)
Bioprojet (7) · Cephalon (7) · Jazz Pharmaceuticals (7) · Alkermes, Inc. (2) · Avadel (2) · Axsome Therapeutics, Inc. (2) · AstraZeneca (1) · Centessa Pharmaceuticals (UK) Limited (1) · Harmony Biosciences Management, Inc. (1) · NLS Pharmaceutics (1) · Orphan Medical (1) · Suven Life Sciences Limited (1) · Takeda (1)
United States (23) · France (15) · Canada (14) · Germany (7) · Netherlands (7) · Switzerland (6) · Australia (5) · Italy (5) · Spain (5) · Belgium (4) · Czechia (4) · Finland (4) · Russia (4) · Hungary (2) · Taiwan (2)
Claudio Bassetti (2) · David Seiden, MD (1) · Evelyne De Paillette, Dr (1) · George Apostol, MD, MS (1) · Giuseppe Plazzi, MD (1) · Harry N Cook, MBA, RPh (1) · Kati Gutierrez, PharmD (1)
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