Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT05156047 · ClinicalTrials.gov registry record · Phase 3
A Phase 3 Study to Assess the Safety and Efficacy of Pitolisant in Adult Patients With Idiopathic Hypersomnia
A Phase 3 study, sponsored by Harmony Biosciences Management.
- Completed
- Registry status
- Phase 3
- Development phase
- 214
- Enrollment target
NCT05156047: Completed Phase 3 study, sponsored by Harmony Biosciences Management.
NCT05156047 is a Phase 3 study that has completed, run by Harmony Biosciences Management. The registered enrollment target is 214 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (72% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05156047, a Phase 3 study, has completed, sponsored by Harmony Biosciences Management.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 214 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 idiopathic hypersomnia (IH) age ≥18 years. Key secondary objectives of this study are to assess the impact of pitolisant on: * Overall symptoms of IH * Patient impression of overall change in their symptoms of IH * Investigator assessment of overall disease severity of IH Other secondary objectives of this study are to assess the impact of pitolisant in patients with IH on: * Patient impression of overall severity of their EDS * Functional status and activities of daily living * Sleep-related impairment * Sleep inertia * Cognitive function
Primary Outcome
Change in Epworth Sleepiness Scale score from the end of the Stable Dose Period to the end of the 4-week Double-Blind Randomized Withdrawal Phase for pitolisant compared with placebo. The score of the Epworth Sleepiness Scale ranges from 0 to 24. A decrease in score represents an improvement in excessive daytime sleepiness.
Interventions
- DRUG Open-label pitolisant
- DRUG Double-blind placebo
- DRUG Double-blind pitolisant
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 214 participants |
| Start Date | 2022-05-25 |
| Est. Completion | 2023-09-08 |
| Phase | Phase 3 |
What the finished NCT05156047 record still lists
NCT05156047 is an interventional study that assigns participants to a tested intervention. The registered 214 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (72% lower).
The record links to 0 conditions, and to 3 interventions - of which Open-label pitolisant is the first listed.
NCT05156047 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05156047 about?
NCT05156047 is a clinical study titled "A Phase 3 Study to Assess the Safety and Efficacy of Pitolisant in Adult Patients With Idiopathic Hypersomnia". 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 idiopathic hypersomnia (IH) age ≥18 years. Key secondary objectives of this study are to assess the impact of pitolisant on:...
What is the current status of trial NCT05156047?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 214 participants. The study started on 2022-05-25. Estimated completion is 2023-09-08.
What interventions are being tested in trial NCT05156047?
The interventions under investigation include: Open-label pitolisant (DRUG), Double-blind placebo (DRUG), Double-blind pitolisant (DRUG).
Who is sponsoring clinical trial NCT05156047?
This trial is sponsored by Harmony Biosciences Management, which has 10 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05156047's enrollment target sits among peer trials
214 1335th of 2000 higher than 666 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT04030507 · 214 participants · NA
Screening Magnetic Resonance Imaging of the Brain in Patients With Breast Cancer
- NCT04421248 · 214 participants · Phase 4
Biomarker Validation in Motor System Physiology in Attention Deficit Hyperactivity Disorder
- NCT04667520 · 214 participants · NA
Testing a Lifestyle Physical Activity Intervention for Women With Depression in Alcohol Treatment
- NCT05418868 · 214 participants · Phase 1
A Study to Investigate Pharmacokinetics, Safety and Tolerability of Long-Acting Cabotegravir Plus Recombinant Human Hyaluronidase PH20 in Healthy Adult Participants
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI