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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
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
A female of child-bearing potential must have a negative urine pregnancy test at the Screening Visit
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to approximately 3 years
Awards & highlights

Study Summary

This trial is assessing the long-term safety and effectiveness of pitolisant in patients with idiopathic hypersomnia who completed the previous phase of the study.

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.Check my eligibility
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.See study design
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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My drug screen was negative, except for prescribed medications.
Select...
I am a woman who can have children and my pregnancy test was negative.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to approximately 3 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to approximately 3 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Excessive daytime sleepiness
Safety and tolerability of pitolisant
Secondary outcome measures
Functional outcomes of sleep
Sleep inertia
Sleep related impairments during wakefulness
+1 more

Trial 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

Find a Location

Who is running the clinical trial?

Harmony Biosciences, LLCLead Sponsor
6 Previous Clinical Trials
1,656 Total Patients Enrolled
1 Trials studying Idiopathic Hypersomnia
214 Patients Enrolled for Idiopathic Hypersomnia

Media Library

Pitolisant (Histamine 3 Receptor Antagonist) Clinical Trial Eligibility Overview. Trial Name: NCT05458128 — Phase 3
Idiopathic Hypersomnia Research Study Groups: Pitolisant
Idiopathic Hypersomnia Clinical Trial 2023: Pitolisant Highlights & Side Effects. Trial Name: NCT05458128 — Phase 3
Pitolisant (Histamine 3 Receptor Antagonist) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05458128 — Phase 3
Idiopathic Hypersomnia Patient Testimony for trial: Trial Name: NCT05458128 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are the risks associated with this healing process?

"This therapeutic intervention has been studied multiple times and has shown to be effective and safe. We rate its safety at a 3."

Answered by AI

Are there any other places in Canada conducting this research?

"To avoid extensive travelling, patients are encouraged to choose a trial site from the 64 locations that are currently enrolling. These locations include Norwalk, Chicago, Willow Grove and many others."

Answered by AI

Are there any more positions available for participants in this clinical trial?

"Unfortunately, this specific trial is not seeking new patients at the moment. The trial was initially posted on 8/19/2022 and was last edited on 9/21/2022. Having said that, there are 21 other trials that are looking for participants right now."

Answered by AI

Who else is applying?

What state do they live in?
Florida
Texas
What site did they apply to?
Florida Pediatric Research Institute
Neurotrials Research Inc.
FutureSearch Trials of Neurology LP
Other
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
3+

Why did patients apply to this trial?

I have tried multiple medications for sleep- ambien, trazadone, lunesta, rozerem, Tylenol pm, melatonin.
PatientReceived no prior treatments
I have tried multiple drugs that have not worked & I have been without treatment for some time now. I am desperate to find something that helps me stay awake during the day again so I can maintain a normal & healthy lifestyle & so I can go back to work & keep a good job & have no issue driving to & from work, & I need to have some kind of income to provide a good life for my 14 year old daughter & so we will not have to struggle any longer, & so I will not miss anymore of my daughter’s life growing up because I can’t stay awake to be there for her.
PatientReceived no prior treatments
~59 spots leftby Aug 2025