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NCT03433131
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
trial testing Pitolisant in Narcolepsy Without Cataplexy. No longer available.
Quick facts
| Lead sponsor | Harmony Biosciences Management, Inc. |
|---|---|
| Status | NO LONGER AVAILABLE |
| Study type | EXPANDED_ACCESS |
| Sites | 71 locations across United States |
Drugs / interventions tested
- Pitolisant (PITOLISANT) — full drug profile →
Conditions studied
- Narcolepsy Without Cataplexy — all drugs for Narcolepsy Without Cataplexy →
- Narcolepsy With Cataplexy — all drugs for Narcolepsy With Cataplexy →
Sponsor
Harmony Biosciences Management, Inc. — full company profile →
Who can join
18 and older, any sex, with Narcolepsy Without Cataplexy or Narcolepsy With Cataplexy. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This EAP will be open to provide access to treatment with pitolisant while a U.S. New Drug Application (NDA) is being prepared and submitted for review for marketing approval. This program will be open to adult patients in the U.S. with Excessive Daytime Sleepiness (EDS) associated with narcolepsy, with or without cataplexy. Pitolisant will be made available through treating physicians participating in the program.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT03433131
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Pitolisant
Trials testing the same drug.
- NCT05581576 — Pitolisant in Refractory Restless Legs Syndrome · Phase 4 · unknown
- NCT05458128 — A Long-Term Safety and Effectiveness Study to Evaluate Pitolisant in Adult Patients With Idiopathic Hypersomnia · Phase 3 · completed
- NCT05223166 — A Clinical Study to Evaluate the Efficacy and Safety of Pitolisant in the Treatment of EDS in Patients With OSA · Phase 3 · completed
- NCT04596267 — Pitolisant Effects on Alcohol Self-Administration in Heavy Drinkers · Phase 1 · terminated
- NCT05536011 — WAKIX® (Pitolisant) Pregnancy Registry · recruiting
Other Harmony Biosciences Management, Inc. trials
Trials by the same sponsor.
- NCT06930872 — Drug Interaction Study of ZYN002 Transdermal Gel and Probe Substrates · Phase 1 · completed
- NCT07051252 — A Study of HBS-201 (Pitolisant Delayed-release) · Phase 1 · completed
- NCT05458128 — A Long-Term Safety and Effectiveness Study to Evaluate Pitolisant in Adult Patients With Idiopathic Hypersomnia · Phase 3 · completed
- NCT05156047 — A Phase 3 Study to Assess the Safety and Efficacy of Pitolisant in Adult Patients With Idiopathic Hypersomnia · Phase 3 · completed
- NCT05536011 — WAKIX® (Pitolisant) Pregnancy Registry · 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 NCT03433131 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Harmony Biosciences Management, Inc.
- Last refreshed: 28 August 2019
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/NCT03433131.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing