The Sleep Medicine & Research Center is Looking for Potential Research Participants Who Are:
- 18 years of age or older
- Diagnosed with idiopathic hypersomnia
- Experiencing excessive daytime sleepiness (EDS)
Study Purpose
Pitolisant, known commercially as WAKIX® is approved by the US Food and Drug Administration for treatment of symptoms of narcolepsy. It is a medicine that is thought to work by helping people stay awake and focus, by turning on parts of the brain that help with thinking and staying alert. The purpose of this clinical trial is to learn how well HBS-301, a new delayed release formula of pitolisant, may improve EDS in patients with idiopathic hypersomnia.
Study Timeline
Period | Duration |
Screening Period | up to 4 weeks to determine eligibility |
Double-Blind Period | 8-weeks of HBS-301 or placebo* |
Open-Label Extension Period | 1 year of HBS-301 |
Follow-up Period | about 4 weeks |
*During the Double-Blind Treatment Period, eligible participants are assigned by chance (like flipping a coin) to HBS-301 or placebo (a tablet that does not contain study drug). You have a 50% chance of taking HBS-301 or placebo.
Participation lasts about 16 weeks if you only complete the Double-Blind Period.
Study Procedures
The study includes collecting information about your demographics, medical history, general health (blood, urine, vital signs, etc.), sleep, and sleepiness. Some of the visits are in-person (5 minimum) and some can be done remotely (up to 11).
Costs, Reimbursements, and Payments
There are no costs to take part in the study. You are compensated for the visits you complete. There is a stipend of $50 for in-person visits and $25 for each remote visit. Travel costs can be reimbursed, and travel arrangements can be made.
How Do I Get More Information?
Complete the questions below and we will contact you for further information. Or call 314-205-6011.