Phase 3 Epilepsy 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 are 2 years of age or older at the time of giving consent to join the study.
- People (or their parent or legal guardian) who are willing and able to sign a consent form before any study activities begin.
- People who have been diagnosed with Dravet Syndrome (DS) whose seizures are not fully controlled by current seizure medications, and who also meet all of the following conditions:
- Seizures began before 18 months of age
- Development was normal when seizures first started
- There is a history of at least one type of seizure that involves movement and can be counted
- A brain scan (MRI) has shown no structural abnormalities in the outer layer of the brain (beyond any mild changes linked to the natural course of Dravet Syndrome)
- A genetic test has confirmed a mutation in the SCN1A gene
Who may not be able to join:
- People who have a known sensitivity, allergy, or previous exposure to the study drug clemizole HCl.
- People who have taken part in another clinical trial involving an experimental drug or device within the past 90 days, or who plan to join another such trial during this study.
- People whose seizures are caused by illicit drug use (including THC or non-prescription cannabis products), alcohol use, infection, tumours, certain nerve or brain diseases, or other progressive or metabolic conditions — rather than Dravet Syndrome itself.
- People who are currently taking a medication called lorcaserin (though prior use is acceptable if at least 30 days have passed since the last dose).
- People who are currently taking a medication called fenfluramine.
- People who have had epilepsy surgery within the 6 months before the screening visit, or who have epilepsy surgery planned during the study period.
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: Amit Ray, MD, Harmony Biosciences Management, Inc.
Phone: +1 (312) 847-1289
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
Percent Change in Countable Motor Seizures Per 28 Days (CMS-28) in the Titration Plus Maintenance Periods Relative to Baseline; European Union: Percent Change in Countable Motor Seizures Per 28 Days in the Maintenance Period Relative to Baseline
Can't join this trial?
Data last synced from ClinicalTrials.gov: 23 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.