Phase 3 Narcolepsy 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:
- You have been officially diagnosed with Type 1 or Type 2 Narcolepsy (based on a standard sleep disorder classification system) within the last 10 years.
- You experience excessive daytime sleepiness.
- If you are already taking certain regular medications or supplements (including some antidepressants or medications to help with wakefulness), you have been on a steady, unchanged dose for at least 3 months before the screening visit, and you are willing to keep that same dose throughout the study period.
Who may not be able to join:
- Your excessive sleepiness is caused by another medical condition rather than narcolepsy.
- You have used a medication called pitolisant recently (within a specific timeframe before screening — confirm with trial site).
- You have a primary psychiatric condition, such as depression, that has not been well-managed or stable for at least 3 months before the screening visit.
- You have ever been diagnosed with bipolar disorder or psychosis.
- You have active or long-term liver disease, or a history of moderate or severe liver damage.
- Your kidneys are not functioning well enough (based on a specific blood test measuring kidney filtration — confirm with trial site).
- You have a known history of a heart rhythm condition called Long QT Syndrome, or a serious abnormality found on a heart tracing (ECG) test.
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: 847-903-4610
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: 28 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.