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NCT04886518 · ClinicalTrials.gov registry record · Phase 2
Safety and Efficacy of Pitolisant on Excessive Daytime Sleepiness and Other Non-Muscular Symptoms in Patients With Myotonic Dystrophy Type 1
A Phase 2 study, sponsored by Harmony Biosciences Management.
- Completed
- Registry status
- Phase 2
- Development phase
- 30
- Enrollment target
NCT04886518 is a Phase 2 study that has completed, run by Harmony Biosciences Management. The registered enrollment target is 30 participants.
The verdict
NCT04886518, a Phase 2 study, has completed, sponsored by Harmony Biosciences Management.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 30 participants
- Enrollment target
Study Summary
The primary objective of this study is to evaluate the safety and efficacy of pitolisant compared with placebo in treating excessive daytime sleepiness (EDS) in patients with Myotonic Dystrophy Type 1 ages 18 to 65 years. The secondary objectives of this study are to assess the impact of pitolisant on fatigue, cognitive function and the burden of disease along with assessing the long-term safety and effectiveness of pitolisant in patients with Myotonic Dystrophy Type 1 ages 18 to 65 years.
Interventions
- DRUG Placebo oral tablet
- DRUG Pitolisant Oral Tablet
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2021-06-28 |
| Est. Completion | 2024-10-31 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04886518
The ClinicalTrials.gov registry entry for NCT04886518 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 30 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Harmony Biosciences Management, which has 10 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo oral tablet is the first listed.
NCT04886518 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04886518 about?
NCT04886518 is a clinical study titled "Safety and Efficacy of Pitolisant on Excessive Daytime Sleepiness and Other Non-Muscular Symptoms in Patients With Myotonic Dystrophy Type 1". The primary objective of this study is to evaluate the safety and efficacy of pitolisant compared with placebo in treating excessive daytime sleepiness (EDS) in patients with Myotonic Dystrophy Type 1 ages 18 to 65 years. The secondary objectives of this study are to assess the impact of pitolisant...
What is the current status of trial NCT04886518?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 30 participants. The study started on 2021-06-28. Estimated completion is 2024-10-31.
What interventions are being tested in trial NCT04886518?
The interventions under investigation include: Placebo oral tablet (DRUG), Pitolisant Oral Tablet (DRUG).
Who is sponsoring clinical trial NCT04886518?
This trial is sponsored by Harmony Biosciences Management, which has 10 total clinical trials registered on ClinicalTrials.gov.
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