Your session is about to expire
← Back to Search
Histamine 3 Receptor Antagonist
A Phase 3 Study to Assess the Safety and Efficacy of Pitolisant in Adult Patients With Idiopathic Hypersomnia
Verified Trial
Phase 3
Waitlist Available
Research Sponsored by Harmony Biosciences, LLC
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 28 days
Treatment Varies
Follow Up 30 days
Awards & highlights
Pivotal Trial
Summary
This trial is testing pitolisant, a medication that helps people stay awake, in adults with idiopathic hypersomnia (IH) who feel very sleepy during the day. Pitolisant works by increasing certain brain chemicals that help keep you awake. The study aims to see if pitolisant is safe and effective. Pitolisant is a newer drug that has shown good safety and efficacy profiles in previous studies for treating sleepiness in conditions like narcolepsy.
Eligible Conditions
- Excessive Daytime Sleepiness
- Idiopathic Hypersomnia
Timeline
Screening ~ 28 days5 visits
Treatment ~ Varies
Follow Up ~ 30 days14 visits
Screening ~ 28 days
Treatment ~ Varies
Follow Up ~30 days
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Excessive Daytime Sleepiness
Secondary study objectives
Attention
Functional outcomes of sleep
Psychomotor Function
+4 moreAwards & Highlights
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Trial Design
3Treatment groups
Experimental Treatment
Active Control
Placebo Group
Group I: Open-label pitolisantExperimental Treatment1 Intervention
Open-label pitolisant administered once daily in the morning upon wakening for 8 weeks during the Open-Label Phase
Group II: Double-blind pitolisantActive Control1 Intervention
Double-blind pitolisant administered once daily in the morning upon wakening for 4 weeks during the Double-Blind Randomized Withdrawal Phase
Group III: Double-blind placeboPlacebo Group1 Intervention
Matching placebo administered once daily in the morning upon wakening for 4 weeks during the Double-Blind Randomized Withdrawal Phase
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Open-label pitolisant
2022
Completed Phase 3
~220
Find a Location
Logistics
Other reimbursement is provided
Other forms of reimbursement are provided for this trial.
Who is running the clinical trial?
Harmony Biosciences, LLCLead Sponsor
8 Previous Clinical Trials
1,804 Total Patients Enrolled
1 Trials studying Idiopathic Hypersomnia
128 Patients Enrolled for Idiopathic Hypersomnia