A Long-Term Safety and Effectiveness Study to Evaluate Pitolisant in Adult Patients With Idiopathic Hypersomnia
Public ClinicalTrials.gov record NCT05458128. 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
An Open-Label Study to Evaluate the Long-Term Safety and Effectiveness of Pitolisant in Adult Patients With Idiopathic Hypersomnia Who Completed Study HBS-101-CL-010
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The primary objective of this study is to assess the long-term safety and effectiveness of pitolisant in patients with idiopathic hypersomnia (IH) who completed the Double-Blind Randomized Withdrawal Phase of study HBS-101-CL-010.
Study identification
- NCT ID
- NCT05458128
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 119 participants
Conditions and interventions
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
- Aug 19, 2022 (Actual)
- Primary completion
- Oct 1, 2025 (Actual)
- Completion
- Oct 1, 2025 (Actual)
- Last update posted
- Dec 12, 2025
2022 – 2025
United States locations
- U.S. sites
- 32
- U.S. states
- 16
- U.S. cities
- 32
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Cedars-Sinai Medical Towers | Los Angeles | California | 90048 | — |
| Sleep Medicine Specialists of California | San Ramon | California | 94583 | — |
| Meris Clinical Research | Brandon | Florida | 33511 | — |
| St. Francis Medical Institute | Clearwater | Florida | 33765 | — |
| Florida Pediatric Research Institute | Winter Park | Florida | 32789 | — |
| Neurotrials Research Inc. | Atlanta | Georgia | 30328 | — |
| NorthShore University Health System | Glenview | Illinois | 60026 | — |
| OSF HealthCare Saint Francis Medical Center | Peoria | Illinois | 61637 | — |
| Western Michigan University Homer Stryker MD School of Medicine | Kalamazoo | Michigan | 49008 | — |
| Clinical Neurophysiology Services | Sterling Heights | Michigan | 48314 | — |
| 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 | — |
| Sleep Dynamics | Neptune City | New Jersey | 07753 | — |
| Northwell Health | New Hyde Park | New York | 11042 | — |
| 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 | — |
| Ohio Sleep Medicine and Neuroscience Institue | Dublin | Ohio | 43017 | — |
| North Star Medical Research | Middleburg | Ohio | 44130 | — |
| Abington Neurological Associates | Willow Grove | Pennsylvania | 19090 | — |
| Respiratory Specialists | Wyomissing | Pennsylvania | 19610 | — |
| Bogan Sleep Consultants | Columbia | South Carolina | 29201 | — |
| Lowcountry Lung Critical Care | North Charleston | South Carolina | 29406 | — |
| 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 | — |
| 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 NCT05458128, 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 Dec 12, 2025 · Synced Oct 20, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT05458128 live on ClinicalTrials.gov.