10 completed, 1 active not recruiting, 1 no longer available, 1 recruiting. 6 Phase 3, 3 Not applicable, 2 Phase 2, 1 Phase 1, 1 Phase 4.
| Phase | Trials | Status |
|---|---|---|
| Phase 3 | 6 | Completed 4, Active not recruiting 1, Unknown 1 |
| Not applicable | 3 | Completed 2, Recruiting 1 |
| Phase 2 | 2 | Completed 2 |
| Phase 1 | 1 | Completed 1 |
| Phase 4 | 1 | Completed 1 |
Follow Narcolepsy With Cataplexy: new trials by email Literature Review of Narcolepsy With Cataplexy trials Research Report on Narcolepsy With 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 |
|---|---|---|---|---|---|---|
| Decreasing Nightmares in Adults With Narcolepsy Imagery Rehearsal Therapy (IRT) - Narcolepsy, Narcolepsy Type 1 | Not applicable | Recruiting | University of Utah | 80 | 2026-07-01 | 2026-07-15 |
| 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 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 |
| Narcolepsy Nightmare Study Imagery rehearsal therapy, Targeted dream control - Narcolepsy, Narcolepsy Type 1 | Not applicable | Completed | Northwestern University | 7 | 2023-02-22 | 2026-06-30 |
| 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 |
| Awareness and Self-Compassion Enhancing Narcolepsy Treatment Brief MBI, Standard MBI, Extended MBI - Narcolepsy, Narcolepsy Without Cataplexy | Not applicable | Completed | Northwestern University | 60 | 2020-06-15 | 2024-08-20 |
| 'A Profile of Physical Performance Variables in an Out-patient Adult Population With Narcolepsy' Assessment of physical performance variables - Narcolepsy, Narcolepsy 1 | Suspended | University of Dublin, Trinity College | 70 | 2019-10-15 | 2020-06-05 | |
| Clarithromycin Mechanisms in Hypersomnia Syndromes Clarithromycin, Placebo - Narcolepsy Without Cataplexy, Idiopathic Hypersomnia | Phase 2 | Completed | Emory University | 83 | 2019-09-04 | 2026-08-07 |
| 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 |
| 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 |
| Xyrem and Brain Dopamine in Narcolepsy Xyrem - Narcolepsy With Cataplexy, Healthy Controls | Phase 4 | Completed | Centre for Addiction and Mental Health | 17 | 2016-01-01 | 2021-03-23 |
| 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 |
| Exploratory Clinical Study to Evaluate Sodium Oxybate (Xyrem) on Potential Endocrine Changes Sodium Oxybate (Xyrem) - Narcolepsy With Cataplexy | Phase 1 | Completed | UCB Pharma SA | 25 | 2006-04-10 | 2022-04-08 |
| Expanded Access Program to Provide Treatment With Pitolisant to Adult Patients in the U.S. With Excessive Daytime Sleepiness Associated With Narcolepsy With or Without Cataplexy Pitolisant - Narcolepsy Without Cataplexy, Narcolepsy With Cataplexy | No longer available | Harmony Biosciences Management, Inc. | 2019-08-28 |
Narcolepsy (15) · Disorders of Excessive Somnolence (3) · Cataplexy (2) · Idiopathic Hypersomnia (1) · Motor Activity (1) · Narcolepsy 1 (1) · Sleep Wake Disorders (1)
Dyssomnias (15) · Mental Disorders (15) · Nervous System Diseases (15) · Sleep Disorders, Intrinsic (15) · Sleep Wake Disorders (14) · Disorders of Excessive Somnolence (12) · Behavior (1) · Neurologic Manifestations (1) · Pathological Conditions, Signs and Symptoms (1) · Signs and Symptoms (1)
Sodium Oxybate (4) · pitolisant (3) · Clarithromycin (1) · Cognitive Behavioral Therapy (1) · Mazindol (1)
Bioprojet (2) · Jazz Pharmaceuticals (2) · NLS Pharmaceutics (2) · Northwestern University (2) · Centre for Addiction and Mental Health (1) · Emory University (1) · Harmony Biosciences Management, Inc. (1) · Takeda (1) · UCB Pharma SA (1) · University of Dublin, Trinity College (1) · University of Utah (1)
United States (9) · France (4) · Italy (3) · Netherlands (3) · Belgium (2) · Finland (2) · Spain (2) · Canada (1) · Czechia (1) · Germany (1) · Hungary (1) · Ireland (1) · Russia (1) · Switzerland (1)
Jennifer Mundt, PhD (2) · Carlos Camozzi, MD (1) · Evelyne De Paillette, Dr (1) · George Apostol, MD, MS (1) · Giuseppe Plazzi, MD (1) · Lynn Marie Trotti, MD, MSc (1) · Michael Thorpy, MD (1) · Stephen J Kish, Ph.D. (1)
PMID 28129985, PMID 30169321, PMID 33184650, PMID 34822113, PMID 34920345, PMID 34935103, PMID 35635687, PMID 35689598, PMID 36931805, PMID 36947322, PMID 37942930, PMID 38895897
2005 (1), 2016 (1), R01NS111280 (1), R34AT009551 (1)