A Long-Term Safety and Effectiveness Study to Evaluate Pitolisant in Adult Patients With Idiopathic Hypersomnia
NCT ID: NCT05458128
Last Updated: 2025-12-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
119 participants
INTERVENTIONAL
2022-08-19
2025-10-01
Brief Summary
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Detailed Description
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Enrolled patients will be dispensed open-label pitolisant and may be titrated up to a maximum dose of 35.6 mg, based on the Investigator's assessment of safety/tolerability and effectiveness, during a 3-week Titration Period (Day 1 to Day 21) in accordance with the schedule:
* Week 1 (Day 1-7), 8.9 mg
* Week 2 (Day 8-14), 17.8 mg
* Week 3 (Day 15-21), 35.6 mg
The Long-Term Dosing Period will begin on Day 22 and will continue until the patient discontinues from the study or the Sponsor elects to terminate the study (i.e., End-of-Study \[EOS\]).
An on-site study visit will occur approximately 180 days after Visit 2 on Day 202 (Visit 3). On-site study visits will occur approximately every 6 months and telephone contacts (TCs) approximately every one month in between until the patient withdraws from the study or the study is terminated by the Sponsor. The dose of pitolisant may be adjusted (higher or lower) in increments of 4.45 mg starting at 8.9 mg up to 35.6 mg during the Long-Term Dosing Period based on Investigator assessment of safety/tolerability and effectiveness.
All patients will receive safety follow-up TCs from the study site 15 days and 30 days after their final dose of pitolisant, to assess for adverse events (AEs) and concomitant medication use.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Pitolisant
Week 1: 8.9 mg pitolisant administered once daily in the morning upon wakening; Week 2: 17.8 mg pitolisant administered once daily in the morning upon wakening; Weeks 3 through end of treatment: 17.8 mg to 35.6 mg pitolisant administered once daily in the morning upon wakening.
Pitolisant
Pitolisant 4.45 mg tablets
Pitolisant 17.8 mg tablets
Interventions
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Pitolisant
Pitolisant 4.45 mg tablets
Pitolisant 17.8 mg tablets
Eligibility Criteria
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Inclusion Criteria
2. Completed the Double-Blind Randomized Withdrawal Phase (EOT/Visit 5) from the HBS-101-CL-010 study.
3. 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.
4. 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.
5. In the opinion of the Investigator, the patient is capable of understanding and complying with the protocol and administration of oral study drug.
Exclusion Criteria
2. 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.
3. Participation in an interventional research study with an investigational medication or device, other than pitolisant, for the duration of the study.
4. 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).
5. Is receiving or is unable to discontinue a medication known to prolong the QT interval.
6. 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.
7. 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.
18 Years
ALL
No
Sponsors
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Harmony Biosciences Management, Inc.
INDUSTRY
Responsible Party
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Locations
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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
Lowcountry Lung Critical Care
North Charleston, South Carolina, United States
Neurology Clinic, P.C.
Cordova, Tennessee, United States
FutureSearch Trials of Neurology LP
Austin, Texas, United States
Central Texas Neurology Consultants, PA
Round Rock, Texas, United States
Comprehensive Sleep Medicine Associates
Sugar Land, Texas, United States
Northwest Houston Neurology and Sleep
Tomball, Texas, United States
University of Wisconsin-Madison
Madison, Wisconsin, United States
Countries
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Other Identifiers
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HBS-101-CL-011
Identifier Type: -
Identifier Source: org_study_id
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