Trials / No Longer Available
No Longer AvailableNCT03433131
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
An Open Label Expanded Access Program Intended to Provide Treatment With HBS-101 (Pitolisant) to Adult Patients in the U.S. With Excessive Daytime Sleepiness Associated With Narcolepsy With or Without Cataplexy
- Status
- No Longer Available
- Phase
- —
- Study type
- Expanded Access
- Enrollment
- —
- Sponsor
- Harmony Biosciences Management, Inc. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- —
Summary
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Pitolisant | Tablets |
Timeline
- First posted
- 2018-02-14
- Last updated
- 2019-08-28
Locations
71 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT03433131. Inclusion in this directory is not an endorsement.