Phase 3 Sleep Disorders Trial, Recruiting
Who may be able to join
AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI
Who might be able to join this trial:
- People who have been formally diagnosed with Idiopathic Hypersomnia (IH) — a sleep disorder causing excessive sleepiness — according to recognised international diagnostic guidelines, with supporting sleep study results on file from within the last 10 years.
- People who experience excessive daytime sleepiness (feeling very sleepy during the day).
- People whose IH symptoms are rated as moderate to very severe.
- People who are taking certain ongoing medications or supplements (including some antidepressants or wakefulness-promoting medicines) at a stable dose for at least 3 months before the screening visit, and who are willing to keep that dose unchanged during the treatment part of the study.
Who may not be able to join:
- People whose excessive sleepiness is caused by another medical condition rather than IH itself.
- People who have used a medication called pitolisant within a certain period before the screening visit (confirm with trial site for exact timing).
- People who have a primary diagnosis of a psychiatric condition, including depression, that is not well managed or controlled.
- People who have a history of moderate or severe liver problems.
- People whose kidneys are not functioning above a certain level, based on a specific medical measurement (confirm with trial site).
- People who have a known history of a heart rhythm condition called long QT syndrome, or any significant abnormal heart electrical activity found on a heart tracing (ECG).
- People who use certain wakefulness medications — such as stimulants, modafinil, or armodafinil — on an as-needed basis are not permitted to continue that use during the study.
Important: Always verify eligibility with the trial site directly before applying.
Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.
Contact this trial
Principal Investigator: David Seiden, MD, Harmony Biosciences Management, Inc.
Phone: 443-309-5556
Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.
GP referral letter
Print a one-page summary to share with your doctor.
Trial details
Where this trial is recruiting
Primary endpoints
Change in severity of EDS as measured by the Epworth Sleepiness Scale (ESS)
Can't join this trial?
Data last synced from ClinicalTrials.gov: 14 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.