WAKIX® (Pitolisant) Pregnancy Registry
- Conditions
- Pregnancy RelatedNarcolepsy
- Interventions
- Drug: Comparator Products
- First Posted Date
- 2022-09-10
- Last Posted Date
- 2024-01-25
- Lead Sponsor
- Harmony Biosciences, LLC
- Target Recruit Count
- 1329
- Registration Number
- NCT05536011
- Locations
- 🇺🇸
Evidera (PPD), Morrisville, North Carolina, United States
A Long-Term Safety and Effectiveness Study to Evaluate Pitolisant in Adult Patients With Idiopathic Hypersomnia
- Conditions
- Idiopathic HypersomniaExcessive Daytime Sleepiness
- Interventions
- First Posted Date
- 2022-07-14
- Last Posted Date
- 2024-01-25
- Lead Sponsor
- Harmony Biosciences, LLC
- Target Recruit Count
- 128
- Registration Number
- NCT05458128
- Locations
- 🇺🇸
Clinical Neurophysiology Services, Sterling Heights, Michigan, United States
🇺🇸Western Michigan University Homer Stryker MD School of Medicine, Kalamazoo, Michigan, United States
🇺🇸Sleep Dynamics, Neptune City, New Jersey, United States
A Phase 3 Study to Assess the Safety and Efficacy of Pitolisant in Adult Patients With Idiopathic Hypersomnia
- Conditions
- Idiopathic Hypersomnia
- Interventions
- First Posted Date
- 2021-12-14
- Last Posted Date
- 2024-02-06
- Lead Sponsor
- Harmony Biosciences, LLC
- Target Recruit Count
- 214
- Registration Number
- NCT05156047
- Locations
- 🇺🇸
Santa Monica Clinical Trials, Santa Monica, California, United States
🇺🇸Lowcountry Lung Critical Care, North Charleston, South Carolina, United States
🇺🇸NorthShore Uni HealthSys-Glenbrook Hospital, Glenview, Illinois, United States
A Phase 2 Study to Evaluate the Safety and Efficacy of Pitolisant in Patients With Prader-Willi Syndrome, Followed by an Open Label Extension
- Conditions
- Prader-Willi Syndrome
- Interventions
- Drug: Placebo oral tablet
- First Posted Date
- 2020-02-06
- Last Posted Date
- 2023-09-14
- Lead Sponsor
- Harmony Biosciences, LLC
- Target Recruit Count
- 65
- Registration Number
- NCT04257929
- Locations
- 🇺🇸
CTI, Cincinnati, Ohio, United States
🇺🇸University of Nebraska Medical Center, Omaha, Nebraska, United States
🇺🇸Vanderbilt University Medical Center, Nashville, Tennessee, United States
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
- Conditions
- Narcolepsy Without CataplexyNarcolepsy With Cataplexy
- First Posted Date
- 2018-02-14
- Last Posted Date
- 2019-08-28
- Lead Sponsor
- Harmony Biosciences, LLC
- Registration Number
- NCT03433131
- Locations
- 🇺🇸
St. Lukes Hospital, Sleep Medicine, Chesterfield, Missouri, United States
🇺🇸Emory University, Atlanta, Georgia, United States
🇺🇸Northwestern Medical Group, Chicago, Illinois, United States