Pitolisant for Idiopathic Hypersomnia

Phase-Based Progress Estimates
Idiopathic Hypersomnia+1 More
Pitolisant Oral Tablet - Drug
All Sexes
What conditions do you have?

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
  • Idiopathic Hypersomnia

Treatment Effectiveness

Effectiveness Progress

2 of 3
This is further along than 85% of similar trials

Study Objectives

1 Primary · 7 Secondary · Reporting Duration: Week 8 to Week 12

Week 12
Excessive Daytime Sleepiness
Functional outcomes of sleep
Psychomotor Function
Sleep inertia
Sleep related impairments during wakefulness
Symptoms of idiopathic hypersomnia
Working Memory

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Trial Design

2 Treatment Groups

1 of 2
Matching Placebo
1 of 2

Active Control

Non-Treatment Group

200 Total Participants · 2 Treatment Groups

Primary Treatment: Pitolisant · Has Placebo Group · Phase 3

Matching Placebo
PlaceboComparator Group · 1 Intervention: Placebo oral tablet · Intervention Types: Drug
ActiveComparator Group · 1 Intervention: Pitolisant Oral Tablet · Intervention Types: Drug

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: week 8 to week 12

Who is running the clinical trial?

Harmony Biosciences, LLCLead Sponsor
6 Previous Clinical Trials
1,613 Total Patients Enrolled
1 Trials studying Idiopathic Hypersomnia
128 Patients Enrolled for Idiopathic Hypersomnia

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have a current diagnosis of idiopathic intracranial hypertension.
You are male or female.
You have an ESS score of ≥12 at Screening and at Baseline (Visit 2).
You must have a negative urine drug screen at the Screening Visit, Baseline Visit (Visit 2) and at the end of the Stable Dose Period (Visit 4), except for medications that are prescribed by a healthcare provider for medical conditions.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 3rd, 2021

Last Reviewed: November 5th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.

Who else is applying?

What state do they live in?
North Carolina50.0%
How old are they?
18 - 6550.0%
< 1850.0%
What site did they apply to?
Northwestern University50.0%
Raleigh Neurology Associates50.0%
What portion of applicants met pre-screening criteria?
Met criteria100.0%
How many prior treatments have patients received?