A Phase 3 Study to Assess the Safety and Efficacy of Pitolisant in Adult Patients With Idiopathic Hypersomnia
Public ClinicalTrials.gov record NCT05156047. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Double-Blind, Placebo-Controlled, Randomized Withdrawal Study to Evaluate the Safety and Efficacy of Pitolisant in Adult Patients With Idiopathic Hypersomnia
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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 participants 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 * Participant 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 participants with IH on: * Participant impression of overall severity of their EDS * Functional status and activities of daily living * Sleep-related impairment * Sleep inertia * Cognitive function
Study identification
- NCT ID
- NCT05156047
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 214 participants
Conditions and interventions
Conditions
Interventions
- Open-label Pitolisant Drug
- Double-blind Placebo Drug
- Double-blind Pitolisant Drug
Drug
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- May 25, 2022 (Actual)
- Primary completion
- Sep 8, 2023 (Actual)
- Completion
- Sep 8, 2023 (Actual)
- Last update posted
- Sep 25, 2026
2022 – 2023
United States locations
- U.S. sites
- 58
- U.S. states
- 25
- U.S. cities
- 56
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Phoenix Medical Group | Peoria | Arizona | 85381 | — |
| Mayo Clinic | Scottsdale | Arizona | 85259 | — |
| Cedars-Sinai Medical Towers | Los Angeles | California | 90048 | — |
| University of California- Los Angeles | Los Angeles | California | 90095 | — |
| Sleep Medicine Specialists of California | San Ramon | California | 94583 | — |
| SDS Clinical Trials Inc. | Santa Ana | California | 92705 | — |
| Santa Monica Clinical Trials | Santa Monica | California | 90404 | — |
| Alpine Clinical Research Center | Boulder | Colorado | 80301 | — |
| Norwalk Hospital Sleep Center | Norwalk | Connecticut | 06850 | — |
| Meris Clinical Research | Brandon | Florida | 33511 | — |
| St. Francis Medical Institute | Clearwater | Florida | 33765 | — |
| Sleep Medicine Specialists of South Florida, PA | Miami | Florida | 33126 | — |
| Pasadena Center For Medical Research, LLC | St. Petersburg | Florida | 33763 | — |
| Florida Pediatric Research Institute | Winter Park | Florida | 32789 | — |
| Neurotrials Research Inc. | Atlanta | Georgia | 30328 | — |
| The Neurological Center of North GA | Gainesville | Georgia | 30501 | — |
| Northwestern University | Chicago | Illinois | 60611 | — |
| NorthShore Uni HealthSys-Glenbrook Hospital | Glenview | Illinois | 60026 | — |
| OSF HealthCare Saint Francis Medical Center | Peoria | Illinois | 61637 | — |
| Helene A. Emsellem MD PC | Chevy Chase | Maryland | 20815 | — |
| Boston Children's Hospital | Boston | Massachusetts | 02115 | — |
| Neurocare, INC | Newton | Massachusetts | 02459 | — |
| Henry Ford Health System | Novi | Michigan | 48377 | — |
| Bronson Sleep Health | Portage | Michigan | 49024 | — |
| Clinical Neurophysiology Services | Sterling Heights | Michigan | 48314 | — |
| Minnesota Lung Center | Edina | Minnesota | 55125 | — |
| Minnesota Lung Center | Woodbury | Minnesota | 55125 | — |
| St. Luke's Sleep Medicine and Research Center | Chesterfield | Missouri | 63017 | — |
| Clayton Sleep Institute | St Louis | Missouri | 63123 | — |
| Great Plains Health | North Platte | Nebraska | 69101 | — |
| Neurology Specialists of Monmouth County, PA | West Long Branch | New Jersey | 07764 | — |
| Northwell Health | New Hyde Park | New York | 11042 | — |
| Research Carolina Elite LLC | Denver | North Carolina | 28037 | — |
| Duke University School of Medicine | Durham | North Carolina | 27705 | — |
| Clinical Research of Gastonia | Gastonia | North Carolina | 28054 | — |
| ARSM Research | Huntersville | North Carolina | 28078 | — |
| NeuroScience Research Center, LLC | Canton | Ohio | 44718 | — |
| Intrepid Research, LLC | Cincinnati | Ohio | 45245 | — |
| Rainbow Babies Children's Hospital | Cleveland | Ohio | 44106 | — |
| Cleveland Clinic | Cleveland | Ohio | 44195 | — |
| Ohio Sleep Medicine and Neuroscience Institute | Dublin | Ohio | 43017 | — |
| North Star Medical Research | Middleburg | Ohio | 44130 | — |
| CardioVoyage | Ardmore | Oklahoma | 73401 | — |
| Brian Abaluck, LLC | Paoli | Pennsylvania | 19301 | — |
| Abington Neurological Associates | Willow Grove | Pennsylvania | 19090 | — |
| Respiratory Specialists | Wyomissing | Pennsylvania | 19610 | — |
| Medical University of South Carolina- Institute of Psychiatry | Charleston | South Carolina | 29425 | — |
| Bogan Sleep Consultants | Columbia | South Carolina | 29201 | — |
| Lowcountry Lung Critical Care | North Charleston | South Carolina | 29406 | — |
| Advanced Center for Sleep Disorders | Chattanooga | Tennessee | 37421 | — |
| Neurology Clinic, P.C. | Cordova | Tennessee | 38018 | — |
| FutureSearch Trials of Neurology LP | Austin | Texas | 78731 | — |
| Central Texas Neurology Consultants, PA | Round Rock | Texas | 78681 | — |
| Comprehensive Sleep Medicine Associates | Sugar Land | Texas | 77478 | — |
| Northwest Houston Neurology and Sleep | Tomball | Texas | 77375 | — |
| Children's Hospital of the King's Daughter | Norfolk | Virginia | 23507 | — |
| West Virginia University - Department of Neurology | Morgantown | West Virginia | 26506 | — |
| University of Wisconsin-Madison | Madison | Wisconsin | 53719 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT05156047, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Sep 25, 2026 · Synced Oct 21, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT05156047 live on ClinicalTrials.gov.