# A Long-Term Safety and Effectiveness Study to Evaluate Pitolisant in Adult Patients With Idiopathic Hypersomnia

> **NCT05458128** · PHASE3 · COMPLETED · sponsor: **Harmony Biosciences Management, Inc.** · enrollment: 119 (actual)

## Conditions studied

- Idiopathic Hypersomnia
- Excessive Daytime Sleepiness

## Interventions

- **DRUG:** Pitolisant

## Key facts

- **NCT ID:** NCT05458128
- **Lead sponsor:** Harmony Biosciences Management, Inc.
- **Sponsor class:** INDUSTRY
- **Phase:** PHASE3
- **Study type:** INTERVENTIONAL
- **Status:** COMPLETED
- **Start date:** 2022-08-19
- **Primary completion:** 2025-10-01
- **Final completion:** 2025-10-01
- **Target enrollment:** 119 (ACTUAL)
- **Last updated:** 2025-12-12


## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT05458128

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT05458128, "A Long-Term Safety and Effectiveness Study to Evaluate Pitolisant in Adult Patients With Idiopathic Hypersomnia". Retrieved via AI Analytics 2026-06-03 from https://api.ai-analytics.org/clinical/NCT05458128. Licensed CC0.

---

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