The Sleep Medicine & Research Center is Looking for Potential Research Participants Who Are:
- 18 years of age or older
- Diagnosed with idiopathic hypersomnia (IH)
- Experiencing excessive daytime sleepiness (EDS)
Study Purpose
St. Luke’s Hospital is testing a new investigational delayed-release formula of pitolisant for patients with IH.
Pitolisant is a medicine that is thought to help people stay awake by increasing histamine in the brain. Pitolisant, known commercially as WAKIX® is approved by the US Food and Drug Administration (FDA) for treatment of excessive daytime sleepiness and cataplexy in patients 6 years of age and older with narcolepsy. HBS-301 (pitolisant delayed-release tablet) is a new formulation of pitolisant. HBS-301 is an investigational drug that is not approved by the US FDA and is different from the commercial form of pitolisant (WAKIX®).The purpose of this clinical trial is to learn whether this investigational formulation of pitolisant may be effective for patients with IH.
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.), heart function, sleep, and sleepiness. Some of the visits are in-person (5 minimum) and some can be done remotely (up to 11). As with any investigational drug, there may be risks associated with your participation. These will be discussed with you in detail if you are eligible for the study.
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. Additional stipends may also apply for eligible participants following the Double-Blind Period. Travel costs can be reimbursed, and travel arrangements can be made.
To Learn More
Contact us at: 314-205-6011 or complete the form below.