# A Phase 3 Study to Assess the Safety and Efficacy of Pitolisant in Adult Patients With Idiopathic Hypersomnia

> **NCT05156047** · PHASE3 · COMPLETED · sponsor: **Harmony Biosciences Management, Inc.** · enrollment: 214 (actual)

## Conditions studied

- Idiopathic Hypersomnia

## Interventions

- **DRUG:** Open-label pitolisant
- **DRUG:** Double-blind placebo
- **DRUG:** Double-blind pitolisant

## Key facts

- **NCT ID:** NCT05156047
- **Lead sponsor:** Harmony Biosciences Management, Inc.
- **Sponsor class:** INDUSTRY
- **Phase:** PHASE3
- **Study type:** INTERVENTIONAL
- **Status:** COMPLETED
- **Start date:** 2022-05-25
- **Primary completion:** 2023-09-08
- **Final completion:** 2023-09-08
- **Target enrollment:** 214 (ACTUAL)
- **Last updated:** 2024-09-19


## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT05156047

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT05156047, "A Phase 3 Study to Assess the Safety and Efficacy of Pitolisant in Adult Patients With Idiopathic Hypersomnia". Retrieved via AI Analytics 2026-06-24 from https://api.ai-analytics.org/clinical/NCT05156047. Licensed CC0.

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