← Back to Search

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

Study Summary

This trial will assess the safety and efficacy of pitolisant compared to placebo in treating excessive daytime sleepiness in patients with idiopathic hypersomnia.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Excessive Daytime Sleepiness
Secondary outcome measures
Attention
Functional outcomes of sleep
Psychomotor Function
+4 more

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
7 Previous Clinical Trials
1,704 Total Patients Enrolled
1 Trials studying Idiopathic Hypersomnia
128 Patients Enrolled for Idiopathic Hypersomnia

Frequently Asked Questions

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

In how many different medical clinics is this clinical trial being run today?

"To make participating as easy as possible for patients, the clinical trial is happening at 62 locations. If you choose to be a part of this study, select the site that is closest to your home to minimize travel. The locations are listed below."

Answered by AI

What health issues does Pitolisant help to alleviate?

"Uses of Pitolisant include the treatment of Excessive Daytime Sleepiness, Narcolepsy with Cataplexy, and just Narcolepsy."

Answered by AI

Is this research study still looking for participants?

"From what is advertised on clinicaltrials.gov, this research is still looking for volunteers. The first posting was on May 25th, 2022 while the most recent update was on September 16th, 2022."

Answered by AI

What is the projected number of people who will enroll in this clinical trial?

"That is correct. As of now, the medical study is recruiting patients. The trial was initially posted on May 25th, 2020 and updated September 16th, 2020. In total, they are looking for 200 individuals from 62 different locations."

Answered by AI

Has the United States Food and Drug Administration cleared Pitolisant for use?

"There is some evidence of efficacy and multiple instances of safety data, which puts Pitolisant's safety at a 3."

Answered by AI

Are there other examples of Pitolisant being used in a medical setting?

"Currently, there are 3 ongoing studies for Pitolisant. 1 of these is in Phase 3. 82 different medical centres across the globe are running trials for this medication, with the majority of studies taking place in Dublin, Ohio."

Answered by AI

What makes this experiment unique in comparison to others like it?

"Harmony Biosciences, LLC first sponsored a study for Pitolisant in 2021. Since then, there have been 3 clinical trials involving this medication that are currently ongoing in 70 different cities located in 2 countries."

Answered by AI

Who else is applying?

What state do they live in?
North Carolina
Illinois
Other
Texas
How old are they?
< 18
18 - 65
What site did they apply to?
Mayo Clinic
Florida Pediatric Research Institute
Other
Central Texas Neurology Consultants, PA
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
How many prior treatments have patients received?
1
3+
2
0

Why did patients apply to this trial?

I’ve suffered from insomnia for several years and have been unable to find a medication that helps.
PatientReceived 1 prior treatment
I've tried several medications and nothing seems to control my EDS consistently. I drive for a living and it's been affecting my job for the last two years.
PatientReceived 2+ prior treatments
I don't currently have a doctor in Texas to treat my excessive daytime sleepiness. I have taken Modafinil in the past but build a tolerance to it so quickly.
PatientReceived no prior treatments
I have all the symptoms of idiopathic Hypersomnia. No other health conditions. On average I sleep 11-16 hrs per day and have a very difficult time getting out of bed.
PatientReceived 1 prior treatment
I've tried most of the available drugs that were made available and that I could afford. Modafinil had limited success but quickly reached the point I needed the maximum dose to get by. and not long after quit due to ineffectiveness. I did get to try Sunosi but had weird psychological side effects I was not comfortable with and ceased use.
PatientReceived no prior treatments

What questions have other patients asked about this trial?

What is the duration of the study? How long do the screening sessions take?
PatientReceived 1 prior treatment

How responsive is this trial?

Typically responds via
Phone Call
Email
Most responsive sites:
  1. Central Texas Neurology Consultants, PA: < 48 hours
Average response time
  • < 2 Days
Recent research and studies
clinicaltrials.govStudy
A Phase 3 Study to Assess the Safety and Efficacy of Pitolisant in Adult Patients With Idiopathic Hypersomnia
2022. "A Phase 3 Study to Assess the Safety and Efficacy of Pitolisant in Adult Patients With Idiopathic Hypersomnia". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05156047.
All > Idiopathic Hypersomnia
~73 spots leftby May 2025
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top