24 completed, 4 recruiting, 2 unknown. 19 Phase 3, 5 Phase 2, 3 Not applicable.
| Phase | Trials | Status |
|---|---|---|
| Phase 3 | 19 | Completed 14, Recruiting 4, Unknown 1 |
| Phase 2 | 5 | Completed 4, Recruiting 1 |
| Not applicable | 3 | Completed 2, Unknown 1 |
Follow Cataplexy: new trials by email Literature Review of Cataplexy trials Research Report on Cataplexy
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 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 |
| 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 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 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 |
| Spectrometry (MRM) Versus I 125 Radioimmunoassay (RIA) for Quantification of Orexin-A of Patients With Hypersomnolence Quantitative mass spectrometry assay - Narcolepsy, Idiopathic Hypersomnia | Not applicable | Completed | University Hospital, Montpellier | 117 | 2023-02-15 | 2026-07-09 |
| 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 |
| Clinical and Neurophysiological Characteristics of Narcolepsy no intervention - Narcolepsy Type 1 | Completed | I.M. Sechenov First Moscow State Medical University | 89 | 2019-11-01 | 2024-03-13 | |
| 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 |
| 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 |
| Exploration of the Reward System by Functional MRI in Narco-cataplexy Patients With and Without REM Sleep Behavior Disorder fMRI, Videopolysomnography, NC (narcolepsy-cataplexy) - Narcolepsy, Cataplexy | Not applicable | Unknown | University Hospital, Clermont-Ferrand | 66 | 2018-01-19 | 2018-02-09 |
| 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 |
| Cardiovascular Variability and Heart Rate Arousal Response in Idiopathic Hypersomnia Polysomnography - Narcolepsy, Cataplexy | Completed | Centre Hospitalier Universitaire de Saint Etienne | 33 | 2016-01-01 | 2017-01-25 | |
| 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 |
| Risk of Narcolepsy Associated With Administration of H1N1 Vaccine A/H1N1 vaccine - Narcolepsy | Completed | Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal | 24 | 2011-06-01 | 2015-05-14 | |
| 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 |
| Effects of BF2.649 in the Treatment of Excessive Daytime Sleepiness in Narcolepsy. BF2.649, Vigil, palcebo - Treatment of Excessive Daytime Sleepiness in Narcolepsy | Phase 3 | Completed | Bioprojet | 180 | 2010-11-01 | 2017-01-31 |
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Narcolepsy (28) · Disorders of Excessive Somnolence (19) · Sleep Wake Disorders (7) · Fatigue (2) · Hemorrhage (2) · Idiopathic Hypersomnia (2) · Sleepiness (2) · Stroke (2) · Cerebral Hemorrhage (1) · Chronobiology Disorders (1) · Dyssomnias (1) · Ischemia (1) · Ischemic Attack, Transient (1) · Mental Disorders (1)
Sleep Disorders, Intrinsic (30) · Dyssomnias (29) · Mental Disorders (29) · Nervous System Diseases (29) · Sleep Wake Disorders (23) · Disorders of Excessive Somnolence (11) · Pathological Conditions, Signs and Symptoms (11) · Signs and Symptoms (9) · Neurologic Manifestations (7) · Brain Diseases (2) · Cardiovascular Diseases (2) · Central Nervous System Diseases (2) · Cerebrovascular Disorders (2) · Narcolepsy (2) · Pathologic Processes (2)
Modafinil (6) · pitolisant (5) · Reboxetine (3) · Sodium Oxybate (2) · disufenton sodium (2) · samelisant (2) · FANG vaccine (1) · Polysomnography (1) · Solutions (1)
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