# Safety and Efficacy of Pitolisant on Excessive Daytime Sleepiness and Other Non-Muscular Symptoms in Patients With Myotonic Dystrophy Type 1

> **NCT04886518** · PHASE2 · COMPLETED · sponsor: **Harmony Biosciences Management, Inc.** · enrollment: 30 (actual)

## Conditions studied

- Myotonic Dystrophy 1
- Excessive Daytime Sleepiness

## Interventions

- **DRUG:** Pitolisant Oral Tablet
- **DRUG:** Placebo oral tablet

## Key facts

- **NCT ID:** NCT04886518
- **Lead sponsor:** Harmony Biosciences Management, Inc.
- **Sponsor class:** INDUSTRY
- **Phase:** PHASE2
- **Study type:** INTERVENTIONAL
- **Status:** COMPLETED
- **Start date:** 2021-06-28
- **Primary completion:** 2023-10-06
- **Final completion:** 2024-10-31
- **Target enrollment:** 30 (ACTUAL)
- **Last updated:** 2025-04-25


## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT04886518

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT04886518, "Safety and Efficacy of Pitolisant on Excessive Daytime Sleepiness and Other Non-Muscular Symptoms in Patients With Myotonic Dystrophy Type 1". Retrieved via AI Analytics 2026-06-24 from https://api.ai-analytics.org/clinical/NCT04886518. Licensed CC0.

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