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Histamine 3 Receptor Antagonist
Pitolisant for Idiopathic Hypersomnia
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 3 weeks
Treatment Varies
Follow Up up to approximately 3 years
Awards & highlights
Summary
This trial is testing the safety and effectiveness of pitolisant, a medication that helps people stay awake, in adults with idiopathic hypersomnia. These patients have already completed an earlier part of the study. Pitolisant works by boosting brain chemicals that make you feel more alert. It has been approved for the treatment of narcolepsy in adults.
Who is the study for?
This trial is for adults with idiopathic hypersomnia who finished the prior study phase (HBS-101-CL-010) and can follow the study plan. Participants must not use certain drugs, have severe kidney or liver issues, or be at significant suicide risk. Women of childbearing age must test negative for pregnancy and agree to avoid pregnancy during the study.
What is being tested?
The trial is evaluating the long-term safety and effectiveness of a medication called pitolisant in patients with excessive daytime sleepiness due to idiopathic hypersomnia, following their participation in an earlier phase of research.
What are the potential side effects?
While specific side effects are not listed here, participants will be monitored for any adverse reactions to pitolisant throughout the trial to assess its long-term safety profile.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to approximately 3 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to approximately 3 years
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
Safety and tolerability of pitolisant
Secondary study objectives
Functional outcomes of sleep
Sleep inertia
Sleep related impairments during wakefulness
+1 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: PitolisantExperimental Treatment1 Intervention
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pitolisant
2016
Completed Phase 3
~400
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Histamine H3 receptor antagonists/inverse agonists, such as Pitolisant, work by blocking H3 receptors in the brain, which leads to increased release of histamine and other neurotransmitters like dopamine and norepinephrine. This action enhances wakefulness and reduces excessive daytime sleepiness, addressing the core symptoms of Idiopathic Hypersomnia.
This mechanism is crucial for IH patients as it directly targets the neurochemical imbalances that cause their debilitating symptoms, thereby improving their overall quality of life.
[Nonsedative H1 antihistaminics].Treatment of nocturnal asthma.The role of antihistamines in the treatment of vasomotor rhinitis.
[Nonsedative H1 antihistaminics].Treatment of nocturnal asthma.The role of antihistamines in the treatment of vasomotor rhinitis.
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Who is running the clinical trial?
Harmony Biosciences, LLCLead Sponsor
8 Previous Clinical Trials
1,890 Total Patients Enrolled
1 Trials studying Idiopathic Hypersomnia
214 Patients Enrolled for Idiopathic Hypersomnia
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My drug screen was negative, except for prescribed medications.I understand and can follow the study's requirements.I understand and can follow the study's requirements.I have severe kidney disease or severe liver disease.I am a woman who can have children, have a negative pregnancy test, and will use birth control during the study.I am taking or cannot stop taking a medication that affects my heart's rhythm.My drug screen was negative, except for prescribed medications.I am a woman who can have children and my pregnancy test was negative.I agree to use non-hormonal birth control or remain abstinent during and 21 days after the study.
Research Study Groups:
This trial has the following groups:- Group 1: Pitolisant
Awards:
This trial has 2 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Idiopathic Hypersomnia Patient Testimony for trial: Trial Name: NCT05458128 — Phase 3
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