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Phase 3 study of pitolisant for excessive daytime sleepiness in Prader-Willi syndrome
2023-508307-21-00Phase 3Authorised
- Sponsor
- Harmony Biosciences
- Start
- Mar 2025
- Modality
- Small Molecules
- Countries
- 14
01
Overview
Phase 3, randomised, double-blind trial of pitolisant in Prader-Willi syndrome (PWS) (3 arms), sponsored by Harmony Biosciences. Primary endpoint: Change in severity of excessive daytime sleepiness. Planned start Mar 2025; status: authorised.
02
Drugs
pitolisant
03
Conditions
Prader-Willi syndrome (PWS)
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