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Histamine 3 Receptor Antagonist

Pitolisant for 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 days
Treatment ~ Varies
Follow Up ~30 days
This trial's timeline: 28 days for screening, Varies for treatment, and 30 days for reporting.

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 more

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups
Active Control
Placebo Group
Group I: PitolisantActive Control1 Intervention
Dose Optimization Period: 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 6: 17.8 or 35.6 mg pitolisant administered once daily in the morning upon wakening. Stable Dose Period: Weeks 7 through 8: Stable dose of 17.8 or 35.6 mg pitolisant administered once daily in the morning upon wakening. Double-Blind Randomized Withdrawal Phase: Weeks 9 through 12: Stable dose of 17.8 or 35.6 mg pitolisant administered once daily in the morning upon wakening.
Group II: Matching PlaceboPlacebo Group1 Intervention
Double-Blind Randomized Withdrawal Phase: Weeks 9 through 12: Matching placebo tablets.

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
~63 spots leftby Nov 2025
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