Expanded Access Program to Provide Treatment With Pitolisant to Adult Patients in the U.S. With Excessive Daytime Sleepiness Associated With Narcolepsy With or Without Cataplexy
Public ClinicalTrials.gov record NCT03433131. 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 Expanded Access Program Intended to Provide Treatment With HBS-101 (Pitolisant) to Adult Patients in the U.S. With Excessive Daytime Sleepiness Associated With Narcolepsy With or Without Cataplexy
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This EAP will be open to provide access to treatment with pitolisant while a U.S. New Drug Application (NDA) is being prepared and submitted for review for marketing approval. This program will be open to adult patients in the U.S. with Excessive Daytime Sleepiness (EDS) associated with narcolepsy, with or without cataplexy. Pitolisant will be made available through treating physicians participating in the program.
Study identification
- NCT ID
- NCT03433131
- Recruitment status
- No Longer Available
- Study type
- Expanded access
- Phase
- Not listed
- Enrollment
- Not listed
Conditions and interventions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Not listed
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Not listed
- Primary completion
- Not listed
- Completion
- Not listed
- Last update posted
- Aug 28, 2019
United States locations
- U.S. sites
- 71
- U.S. states
- 29
- U.S. cities
- 63
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Sleep Disorders Center of Alabama | Birmingham | Alabama | 35213 | — |
| CPC | Cullman | Alabama | 35058 | — |
| Xenoscience | Phoenix | Arizona | 85004-1150 | — |
| Xenoscience | Phoenix | Arizona | 85004 | — |
| Foothills Neurology | Phoenix | Arizona | 85048 | — |
| Mayo Clinic | Scottsdale | Arizona | 85259 | — |
| Sleep Medicine Specialists of California | San Ramon | California | 94583 | — |
| Santa Monica Sleep Disorders Center | Santa Monica | California | 90404 | — |
| Children's Hospital Colorado | Aurora | Colorado | 80045 | — |
| Colorado Sleep Institute | Boulder | Colorado | 80301 | — |
| Norwalk Hospital Sleep Disorders Center | Norwalk | Connecticut | 06850 | — |
| Clinical Neurosciences fo Tampa Bay | Clearwater | Florida | 33756 | — |
| Mayo Clinic | Jacksonville | Florida | 32224 | — |
| Sleep Medicine Specialists of South Florida, PA | Miami | Florida | 33126 | — |
| Child Lung, Asthma Sleep Specialists | Winter Park | Florida | 32789 | — |
| Emory University | Atlanta | Georgia | 30329 | — |
| NeuroTrials Research Center | Atlanta | Georgia | 30342 | — |
| The Neurological Center of North Georgia | Gainesville | Georgia | 30501 | — |
| Critical Healthcare Decisions | Savannah | Georgia | 31419 | — |
| Northwestern Medical Group | Chicago | Illinois | 60611 | — |
| Rush University Medical Center | Chicago | Illinois | 60637 | — |
| NorthShore Uni HealthSys-Glenbrook Hospital | Glenview | Illinois | 60026 | — |
| Northshore Sleep Medicine | Northbrook | Illinois | 60062 | — |
| Indiana Internal Medicine Consultants | Greenwood | Indiana | 46143 | — |
| The University of Kansas Health System | Fairway | Kansas | 66205 | — |
| Norton Pulmonary Specialists | Louisville | Kentucky | 40218 | — |
| Maine Medical Partners - Neurology | Scarborough | Maine | 04074 | — |
| The Center for Sleep and Wake Disorders | Chevy Chase | Maryland | 20815 | — |
| Boston Children's Hospital | Boston | Massachusetts | 02115 | — |
| The University of Michigan | Ann Arbor | Michigan | 48109 | — |
| Henry Ford Health System | Novi | Michigan | 48377 | — |
| Bronson Sleep Health | Portage | Michigan | 49024 | — |
| Alliance Health Shelby Family Medicine | Shelby | Michigan | 48317 | — |
| Fairview Health Services | Brooklyn Park | Minnesota | 55443 | — |
| Mayo Clinic | Rochester | Minnesota | 55905 | — |
| St. Lukes Hospital, Sleep Medicine | Chesterfield | Missouri | 63017 | — |
| University of Missouri | Columbia | Missouri | 65212 | — |
| Saint Luke's Hospital of Kansas City | Kansas City | Missouri | 64111 | — |
| Norwell Health | New Hyde Park | New York | 11042 | — |
| NYU-FGP Comphrenhensive Epilepsy Center-Sleep Center | New York | New York | 10016 | — |
| Columbia University | New York | New York | 10032 | — |
| Unity Sleep Disorders Center | Rochester | New York | 14618 | — |
| University of Rochester Sleep Center | Rochester | New York | 35058 | — |
| Montefiore Medical Center | The Bronx | New York | 10467 | — |
| Duke University Medical Center | Durham | North Carolina | 27710 | — |
| Excel Psychiatric Associates, PA | Huntersville | North Carolina | 28078 | — |
| Raleigh Neurology Assoc., PA | Raleigh | North Carolina | 27607 | — |
| Neurology & Neuroscience Associates, Inc. | Akron | Ohio | 44320 | — |
| Intrepid Research, LLC | Cincinnati | Ohio | 45245 | — |
| Cleveland Clinic | Cleveland | Ohio | 44195 | — |
| Ohio Sleep Medicine Institute | Dublin | Ohio | 43017 | — |
| Oklahoma Heart Institute | Tulsa | Oklahoma | 74104 | — |
| Oklahoma Heart Institute | Tulsa | Oklahoma | 74133 | — |
| Legacy Medical Group Sleep Medicine | Portland | Oregon | 97210 | — |
| Collegeville Family Practice | Berwyn | Pennsylvania | 19426 | — |
| Paoli Sleep Center | Paoli | Pennsylvania | 19301 | — |
| Thomas Jefferson University | Philadelphia | Pennsylvania | 19107 | — |
| Maria J. Sunseri, MD, LLC | Pittsburgh | Pennsylvania | 15224 | — |
| Abington Neurological Associates | Willow Grove | Pennsylvania | 19090 | — |
| Respitory Specialists | Wyomissing | Pennsylvania | 19610 | — |
| Brown Medicine/Rhode Island Hospital | West Warwick | Rhode Island | 02893 | — |
| Bogan Sleep Consultants | Columbia | South Carolina | 29201 | — |
| Sleep Medicine Associates of Texas | Dallas | Texas | 75231 | — |
| Houston Neurology & Sleep Center | Houston | Texas | 77063 | — |
| Sleep Therapy & Research Center | San Antonio | Texas | 78229 | — |
| Comprehensive Sleep Medicine Associates | Sugar Land | Texas | 77478 | — |
| Chalottesville Neurology and Sleep Medicine | Charlottesville | Virginia | 22911 | — |
| Children's Hospital of The King's Daughters | Norfolk | Virginia | 23507 | — |
| Eastern Virginia Medical School | Norfolk | Virginia | 23507 | — |
| Stultz Sleep and Behavioral Health | Barboursville | West Virginia | 25504 | — |
| Medical College of Wisonsin | Milwaukee | Wisconsin | 53226 | — |
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 NCT03433131, 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 Aug 28, 2019 · Synced Oct 21, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT03433131 live on ClinicalTrials.gov.