17 completed, 6 recruiting, 1 terminated. 24 Phase 2, 2 Phase 3, 1 Phase 1.
| Phase | Trials | Status |
|---|---|---|
| Phase 2 | 24 | Completed 17, Recruiting 6, Terminated 1 |
| Phase 3 | 2 | Recruiting 2 |
| Phase 1 | 1 | Completed 1 |
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 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 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 |
| 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 |
| Extended-release Sodium Oxybate in Children Extended-release sodium oxybate, Non-extended-release oxybates - Narcolepsy Type 1 (NT 1) | Phase 2 | Recruiting | Stanford University | 36 | 2025-10-27 | 2025-11-06 |
| A Long-term Extension Study of ORX750 in Participants With Narcolepsy and Idiopathic Hypersomnia ORX750 - Narcolepsy Type 1, Narcolepsy Type 2 | Phase 2 | Recruiting | Centessa Pharmaceuticals (UK) Limited | 90 | 2025-08-12 | 2026-04-16 |
| 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 Study to Evaluate the Safety and Effectiveness of ALKS 2680 in Subjects With Narcolepsy Type 2 ALKS 2680, Placebo - Narcolepsy Type 2 | Phase 2 | Completed | Alkermes, Inc. | 93 | 2024-07-26 | 2026-02-27 |
| A Study to Evaluate the Safety and Effectiveness of ALKS 2680 in Subjects With Narcolepsy Type 1 (ALKS 2680-201) ALKS 2680, Placebo - Narcolepsy Type 1 | Phase 2 | Completed | Alkermes, Inc. | 92 | 2024-03-24 | 2026-06-10 |
| An Open Label Study of NLS-2 (Mazindol Extended Release) in Subjects With Narcolepsy Mazindol - Narcolepsy With Cataplexy, Narcolepsy | Phase 2 | Completed | NLS Pharmaceutics | 52 | 2021-10-26 | 2023-03-13 |
| 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 |
| A Study to Evaluate Safety, and Efficacy of SUVN-G3031 (Samelisant) in Patients With Narcolepsy With and Without Cataplexy SUVN-G3031, Placebo - Narcolepsy | Phase 2 | Completed | Suven Life Sciences Limited | 190 | 2019-09-21 | 2025-01-13 |
| Clarithromycin Mechanisms in Hypersomnia Syndromes Clarithromycin, Placebo - Narcolepsy Without Cataplexy, Idiopathic Hypersomnia | Phase 2 | Completed | Emory University | 83 | 2019-09-04 | 2026-08-07 |
| Clinical Outcomes in Narcolepsy and Cataplexy: An Evaluation of Reboxetine Treatment (CONCERT) AXS-12 (Reboxetine), Placebo - Narcolepsy, Cataplexy Narcolepsy | Phase 2 | Completed | Axsome Therapeutics, Inc. | 21 | 2019-04-05 | 2026-06-15 |
| A Study to Evaluate the Safety and Efficacy of TS-091 in Patients with Narcolepsy TS-091 5mg, TS-091 10mg, Placebo - Narcolepsy | Phase 2 | Completed | Taisho Pharmaceutical Co., Ltd. | 53 | 2017-10-31 | 2025-02-28 |
| The Effect of Caffeine on the Narcoleptic Patients Vivarin, Fiber - Narcolepsy | Phase 1 / Phase 2 | Completed | King Saud University | 16 | 2016-10-01 | 2019-03-01 |
| Safety and Efficacy of THN102 on Sleepiness in Narcoleptic Patients Active comparator: Modafinil + placebo, THN102 300/3, THN102 300/27 - Narcolepsy | Phase 2 | Completed | Theranexus | 51 | 2016-09-01 | 2020-09-04 |
| Study Assessing Effects of JZP-110 on Driving Performance in the Treatment of Excessive Sleepiness in Narcolepsy JZP-110, Placebo - Narcolepsy, Excessive Sleepiness | Phase 2 | Completed | Jazz Pharmaceuticals | 24 | 2016-06-01 | 2021-01-13 |
| A Study of the Safety and Effectiveness of ADX-N05 for Excessive Daytime Sleepiness in Subjects With Narcolepsy ADX-N05, Placebo - Narcolepsy | Phase 2 | Completed | Jazz Pharmaceuticals | 93 | 2012-09-01 | 2021-05-28 |
| A Study of the Safety and Effectiveness of ADX-N05 in the Treatment of Excessive Daytime Sleepiness ADX-N05, Placebo - Narcolepsy | Phase 2 | Completed | Jazz Pharmaceuticals | 33 | 2011-12-01 | 2021-07-06 |
| Clarithromycin for the Treatment of Hypersomnia Clarithromycin followed by placebo, Placebo then Clarithromycin - Hypersomnia, Idiopathic Hypersomnia | Phase 2 | Completed | Lynn Marie Trotti | 26 | 2010-07-01 | 2017-11-06 |
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Disorders of Excessive Somnolence (11) · Cataplexy (5) · Idiopathic Hypersomnia (4) · Sleep Wake Disorders (3) · Nervous System Diseases (2) · Sleepiness (2) · Cerebral Hemorrhage (1) · Dyssomnias (1) · Hemorrhage (1) · Mental Disorders (1) · Stroke (1)
Sleep Disorders, Intrinsic (24) · Dyssomnias (23) · Mental Disorders (23) · Nervous System Diseases (22) · Sleep Wake Disorders (21) · Disorders of Excessive Somnolence (13) · Pathological Conditions, Signs and Symptoms (5) · Signs and Symptoms (4) · Neurologic Manifestations (3) · Brain Diseases (1) · Cardiovascular Diseases (1) · Central Nervous System Diseases (1) · Cerebrovascular Disorders (1) · Intracranial Hemorrhages (1)
solriamfetol (3) · Clarithromycin (2) · Modafinil (2) · 6-((3-cyclobutyl-2,3,4,5-tetrahydro-1H-3-benzazepin-7-yl)oxy)-N-methyl-3-pyridinecarboxamide (1) · Caffeine (1) · Dietary Fiber (1) · Flecainide (1) · Mazindol (1) · N-ethyl-3-fluoro-3-(3-fluoro-4-(pyrrolidinylmethyl)phenyl)cyclobutanecarboxamide (1) · Reboxetine (1) · Sodium Oxybate (1) · caffeine citrate (1) · disufenton sodium (1) · samelisant (1)
Alkermes, Inc. (3) · Jazz Pharmaceuticals (3) · Centessa Pharmaceuticals (UK) Limited (2) · NLS Pharmaceutics (2) · Alza Corporation, DE, USA (1) · AstraZeneca (1) · Axsome Therapeutics, Inc. (1) · Eisai Inc. (1) · Emory University (1) · GlaxoSmithKline (1) · King Saud University (1) · Lynn Marie Trotti (1) · Pfizer (1) · Stanford University (1) · Suven Life Sciences Limited (1)
United States (19) · Spain (7) · Italy (6) · Belgium (5) · France (5) · Netherlands (5) · Australia (4) · Canada (3) · Czechia (3) · Japan (3) · China (2) · Germany (2) · South Korea (2) · Austria (1) · Finland (1)
Carlos Camozzi, MD (2) · David Ward, MD (1) · Grace Wang, MD (1) · Jan Ramaekers, PhD (1) · Lynn Marie Trotti, MD (1) · Lynn Marie Trotti, MD, MSc (1) · Mona S Aldosari, Masteral (1) · Oliver Sum-Ping, MD (1) · Shigeru Okuyama (1)
PMID 26094838, PMID 26298786, PMID 27166238, PMID 32215834, PMID 32399853, PMID 34031871, PMID 35193545, PMID 36494591, PMID 39504585, PMID 42636845
2025 (2), 2015 (1), R01NS111280 (1)