# A Study of Pitolisant in Participants With Prader-Willi Syndrome

> **NCT07219485** · PHASE3 · ENROLLING_BY_INVITATION · sponsor: **Harmony Biosciences Management, Inc.** · enrollment: 150 (estimated)

## Conditions studied

- Prader-Willi Syndrome

## Interventions

- **DRUG:** Pitolisant

## Key facts

- **NCT ID:** NCT07219485
- **Lead sponsor:** Harmony Biosciences Management, Inc.
- **Sponsor class:** INDUSTRY
- **Phase:** PHASE3
- **Study type:** INTERVENTIONAL
- **Status:** ENROLLING_BY_INVITATION
- **Start date:** 2025-08-20
- **Primary completion:** 2030-08
- **Final completion:** 2030-08
- **Target enrollment:** 150 (ESTIMATED)
- **Last updated:** 2026-03-17


## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT07219485

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT07219485, "A Study of Pitolisant in Participants With Prader-Willi Syndrome". Retrieved via AI Analytics 2026-05-26 from https://api.ai-analytics.org/clinical/NCT07219485. Licensed CC0.

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*[Clinical trials dataset](/datasets/clinical-trials) · CC0 1.0*