A Long-Term Safety and Effectiveness Study to Evaluate Pitolisant in Adult Patients With Idiopathic Hypersomnia

Completed · Phase 3

Conditions studied: Idiopathic Hypersomnia, Excessive Daytime Sleepiness

In brief

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.

Key facts

Study ID

NCT05458128

Run by

Harmony Biosciences Management, Inc.

People needed

119

Starts

2022-08-19

Expected to finish

2025-10-01

Last updated by the study team

2025-12-12

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Is able to provide voluntary, informed consent.
• Completed the Double-Blind Randomized Withdrawal Phase (EOT/Visit 5) from the HBS-101-CL-010 study.
• A patient who is a female of child-bearing potential must have a negative urine pregnancy test at the Screening Visit. A patient who is a female of child-bearing potential must agree to remain abstinent or use an effective method of non-hormonal contraception to prevent pregnancy for the duration of the study and for 21 days after final dose of study drug.
• Must have a negative result on urine drug screen at the Screening Visit, except for medications that are prescribed by a healthcare provider for medical conditions.
• In the opinion of the Investigator, the patient is capable of understanding and complying with the protocol and administration of oral study drug.

You may not qualify if…

• Does not agree to discontinue any prohibited medication or substances listed in the protocol.
• Is currently breastfeeding or planning to breastfeed over the course of the study. Lactating women must agree not to breastfeed for the duration of the study and for 21 days after final dose of study drug.
• Participation in an interventional research study with an investigational medication or device, other than pitolisant, for the duration of the study.
• Has a diagnosis of end-stage renal disease (ESRD; estimated glomerular filtration rate [eGFR] of <15 mL/minute/1.73 m2) or severe hepatic impairment (Child-Pugh C).
• Is receiving or is unable to discontinue a medication known to prolong the QT interval.
• Has a significant risk of committing suicide or suicidality based on history; routine psychiatric examination; Investigator's judgment; or who has an answer of "yes" on any question other than questions 1 to 3 or "yes" on any question in the suicidal behavior section of the C-SSRS, Since Last Visit.
• Based on the judgment of the Investigator, is unsuitable for the study for any reason, including but not limited to an unstable or uncontrolled medical condition or one that might interfere with the conduct of the study, confound interpretation of study results, pose a health risk to the patient, or compromise the integrity of the study.

Where it is running

• Cedars-Sinai Medical Towers — Los Angeles, California, United States
• Sleep Medicine Specialists of California — San Ramon, California, United States
• Meris Clinical Research — Brandon, Florida, United States
• St. Francis Medical Institute — Clearwater, Florida, United States
• Florida Pediatric Research Institute — Winter Park, Florida, United States
• Neurotrials Research Inc. — Atlanta, Georgia, United States
• NorthShore University Health System — Glenview, Illinois, United States
• OSF HealthCare Saint Francis Medical Center — Peoria, Illinois, United States
• Western Michigan University Homer Stryker MD School of Medicine — Kalamazoo, Michigan, United States
• Clinical Neurophysiology Services — Sterling Heights, Michigan, United States
• St. Luke's Sleep Medicine and Research Center — Chesterfield, Missouri, United States
• Clayton Sleep Institute — St Louis, Missouri, United States
• Great Plains Health — North Platte, Nebraska, United States
• Sleep Dynamics — Neptune City, New Jersey, United States
• Northwell Health — New Hyde Park, New York, United States
• Duke University School of Medicine — Durham, North Carolina, United States
• Clinical Research of Gastonia — Gastonia, North Carolina, United States
• ARSM Research — Huntersville, North Carolina, United States
• NeuroScience Research Center, LLC — Canton, Ohio, United States
• Intrepid Research, LLC — Cincinnati, Ohio, United States
• Ohio Sleep Medicine and Neuroscience Institue — Dublin, Ohio, United States
• North Star Medical Research — Middleburg, Ohio, United States
• Abington Neurological Associates — Willow Grove, Pennsylvania, United States
• Respiratory Specialists — Wyomissing, Pennsylvania, United States
• Bogan Sleep Consultants — Columbia, South Carolina, United States

Full record on ClinicalTrials.gov

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