drugset / Trial / NCT05458128
A Long-Term Safety and Effectiveness Study to Evaluate Pitolisant in Adult Patients With Idiopathic Hypersomnia
NaSingle-groupOpen-labelTreatment
Summary
The primary objective of this study is to assess the long-term safety and effectiveness of pitolisant in patients with idiopathic hypersomnia (IH) who completed the Double-Blind Randomized Withdrawal Phase of study HBS-101-CL-010.
Timeline
- Start
- 2022-08-19
- Primary completion
- 2025-10-01
- Completion
- 2025-10-01
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Pitolisant | Small molecule | 17.8 mg | — |
| Subject | Pitolisant | Small molecule | 35.6 mg | — |