Participants will visit their study site at regular times over a period of up to 12 weeks spanning approximately 10 visits (most of which are 1 week apart) for exams and tests by the study doctor, and to receive their supply of study drug. Between study visits, participants will take study drug daily at home and fill in questionnaires about how they feel about their condition.
This clinical study consists of the following study periods:
- A screening period (up to 5 weeks) during which eligibility criteria will be evaluated including a confirmation of participant's IH diagnosis, if needed.
- A 5-week dose optimization period in which all eligible study participants will receive study drug orally once or twice per day. Participants will be assigned into two evenly divided groups. One group will receive a single daily dose just before bedtime, and the other group will receive half the daily dose shortly after awakening and half the daily dose just before bedtime.
- A 2-week double-blind randomized withdrawal period wherein participants receive their optimized dose daily or a matching placebo. “Double-blind” means that study participants and doctors won't know who is receiving active study drug or placebo. “Placebo” is a capsule that looks the same as the active study drug capsule but does not contain active study drug. “Randomized” means that the assignment to active study drug or placebo is random (determined by chance).
For additional details about the study, visit NCT05668754 on clinicaltrials.gov.
