Treatment for Idiopathic Hypersomnia

Phase-Based Progress Estimates
2
Effectiveness
3
Safety
Minnesota Lung Center, Woodbury, MN
Idiopathic Hypersomnia+4 More
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

The primary objective of this study is to assess the long-term safety and effectiveness of pitolisant in patients with idiopathic hypersomnia (IH) who completed the Double-Blind Randomized Withdrawal Phase of study HBS-101-CL-010.

Eligible Conditions

  • Idiopathic Hypersomnia
  • Excessive Daytime Sleepiness

Treatment Effectiveness

Effectiveness Progress

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

Other trials for Idiopathic Hypersomnia

Study Objectives

6 Primary · 0 Secondary · Reporting Duration: Baseline Visit in study HBS-101-CL-010 to month 3, 6, 9, and year 1 and then every year thereafter until End of Treatment Visit

Year 1
Excessive Daytime Sleepiness
Functional outcomes of sleep
Sleep inertia
Sleep related impairments during wakefulness
Symptoms of idiopathic hypersomnia
Screening to 30 (+3) days after final dose
Safety and Tolerability of Pitolisant

Trial Safety

Safety Progress

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

Other trials for Idiopathic Hypersomnia

Trial Design

0 Treatment Group

128 Total Participants · 0 Treatment Group

Primary Treatment: Treatment · No Placebo Group · Phase 3

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: baseline visit in study hbs-101-cl-010 to month 3, 6, 9, and year 1 and then every year thereafter until end of treatment visit
Closest Location: Minnesota Lung Center · Woodbury, MN
2004First Recorded Clinical Trial
3 TrialsResearching Idiopathic Hypersomnia
23 CompletedClinical Trials

Who is running the clinical trial?

Harmony Biosciences, LLCLead Sponsor
5 Previous Clinical Trials
1,667 Total Patients Enrolled
1 Trials studying Idiopathic Hypersomnia
200 Patients Enrolled for Idiopathic Hypersomnia

Eligibility Criteria

Age 18+ · All Participants · 5 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You must have a negative result on a urine drug screen at the Screening Visit.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 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.