4 completed, 1 active not recruiting, 1 unknown. 6 Phase 3.
| Phase | Trials | Status |
|---|---|---|
| Phase 3 | 6 | Completed 4, Active not recruiting 1, Unknown 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 |
|---|---|---|---|---|---|---|
| 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 |
| 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 |
| 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 |
Narcolepsy (6) · Cataplexy (2) · Disorders of Excessive Somnolence (1) · Sleep Wake Disorders (1)
Dyssomnias (6) · Mental Disorders (6) · Nervous System Diseases (6) · Sleep Disorders, Intrinsic (6) · Disorders of Excessive Somnolence (5) · Sleep Wake Disorders (5) · Neurologic Manifestations (1) · Pathological Conditions, Signs and Symptoms (1) · Signs and Symptoms (1)
Sodium Oxybate (2) · pitolisant (2)
Bioprojet (2) · Jazz Pharmaceuticals (2) · NLS Pharmaceutics (1) · Takeda (1)
France (4) · Italy (3) · Netherlands (3) · United States (3) · Finland (2) · Spain (2) · Belgium (1) · Czechia (1) · Germany (1) · Hungary (1) · Russia (1) · Switzerland (1)
Evelyne De Paillette, Dr (1) · George Apostol, MD, MS (1) · Giuseppe Plazzi, MD (1)
PMID 28129985, PMID 30169321, PMID 33184650, PMID 34822113, PMID 34920345, PMID 34935103, PMID 35635687, PMID 35689598, PMID 36931805, PMID 36947322, PMID 37942930
2016 (1)