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NCT06961266
A Study to Investigate Efficacy, Safety, Tolerability, and Pharmacokinetics of JZP441 Compared With Placebo in Participants With Narcolepsy Type 1
Phase 1 trial testing JZP441 in Narcolepsy in 6 participants. Terminated before completion.
29 January 2026
Quick facts
| Lead sponsor | Jazz Pharmaceuticals |
|---|---|
| Phase | Phase 1 |
| Status | Terminated |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | crossover |
| Masking | double |
| Primary purpose | treatment |
| Enrollment | 6 |
| Start date | 13 May 2025 |
| Primary completion | 29 January 2026 |
| Estimated completion | 29 January 2026 |
| Sites | 4 locations across United States |
Drugs / interventions tested
- JZP441 — full drug profile →
- Matching Placebo — full drug profile →
Conditions studied
- Narcolepsy — all drugs for Narcolepsy →
Sponsor
Jazz Pharmaceuticals — full company profile →
Who can join
Adults 18 to 64, any sex, with Narcolepsy. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Narcolepsy is a sleep disorder in which patients are not able to maintain wakefulness or require treatment to maintain wakefulness during the daytime. Narcolepsy is a lifelong neurologic disease for which no cure has been clinically available. JZP441 is currently being developed for the treatment of narcolepsy type 1 (NT1). This study will assess the safety of efficacy of JZP441 in adult patients with NT1.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Hypocretin: a promising target for the regulation of homeostasis.
Wang Y, Fu S, Mao J, Cui K, et al · · 2025 · cited 2× · PMID 40927422 · DOI 10.3389/fnins.2025.1638270
Verify or expand the search:
- PubMed search for NCT06961266
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of JZP441
Trials testing the same drug.
- NCT05720494 — A Multiple Ascending Dose Study to Investigate the Safety, Tolerability, and Pharmacokinetics of JZP441 in Healthy Parti · Phase 1 · completed
- NCT05651152 — A Study to Investigate The Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of JZP441 in Sleep-deprived Heal · Phase 1 · completed
Other recruiting trials for Narcolepsy
Currently open trials in the same condition.
- NCT06797284 — The Impact of Light, Electrical, and Magnetic Neuroregulation Interventions on Sleep-wake Disorders · NA · recruiting
- NCT06586138 — Study of Psychological, Sociological and Professional Factors Associated With Maintenance of Wakefulness Test · recruiting
- NCT04806620 — Unhide® Project: A Digital Health Platform to Collect Lifestyle Data for Brain Inflammation Research · recruiting
- NCT05615584 — Spectrometry (MRM) Versus I 125 Radioimmunoassay (RIA) for Quantification of Orexin-A of Patients With Hypersomnolence · NA · recruiting
- NCT06279247 — Proteomics and Metabolomics of Body Fluid in Patients With Narcolepsy · recruiting
Other Jazz Pharmaceuticals trials
Trials by the same sponsor.
- NCT07533942 — A Study of JZP3507 (ONC206) in Recurrent Grade 2 or 3 Meningioma · Phase 2 · not yet recruiting
- NCT07459634 — A Study of Lurbinectedin in Combination With Durvalumab for the Treatment of Participants With ES-SCLC · Phase 2 · not yet recruiting
- NCT07377539 — A Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Food Effect of JZP047 in Healthy Participants · Phase 1 · not yet recruiting
- NCT07282587 — Study of ONC206 (JZP3507) in Advanced Pheochromocytoma and Paraganglioma · Phase 2 · recruiting
- NCT07233239 — A Study to Evaluate the Efficacy and Safety of Cannabidiol Oral Solution (CBD-OS [GWP42003-P, JZP926]) for the Treatment · Phase 1 · recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06961266 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Jazz Pharmaceuticals
- Last refreshed: 6 April 2026
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06961266.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing