Clemizole HCl for Lennox-Gastaut Syndrome
This study is testing a drug called Clemizole HCl to see if it can help people with Lennox-Gastaut Syndrome (LGS), a severe form of epilepsy. Researchers want to find out if Clemizole HCl is safe and effective when added to a patient's current medications. You might be able to join if you are between 2 and 55 years old and have been diagnosed with LGS, including having at least one type of major motor seizure. The main way success will be measured is by looking at the percentage change in your seizures over 16 weeks. The study plans to enroll 260 participants, but its current recruitment status is unclear.
- Study design
- This is a Phase 3, randomized, double-blind, placebo-controlled study involving approximately 260 participants. This means some participants will receive Clemizole HCl and others will receive a placebo (an inactive substance) without knowing which they are getting.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- The primary endpoint measures changes up to 16 weeks, and there is an optional Open-Label Extension Period, but the total follow-up duration is not specified.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
An Efficacy and Safety Study of Clemizole HCl in Patients With Lennox-Gastaut Syndrome
At a glance
Conditions
NCT05066217
Where you'd take part
This study runs at 58 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.
Atrium Health STRIVE Research
Charlotte, North Carolinastudy coordinator listed
Recruiting
Children's Nebraska
Omaha, Nebraskastudy coordinator listed
Recruiting
Duke University Medical Center
Durham, North Carolinastudy coordinator listed
Recruiting
Minnesota Epilepsy Group, P.A.
Roseville, Minnesotastudy coordinator listed
Recruiting
Norton Children's Medical Center
Louisville, Kentuckystudy coordinator listed
Recruiting
On-Site Clinical Solution
Charlotte, North Carolinastudy coordinator listed
Recruiting
PPD Virtual-Science 37, Inc.
Morrisville, North Carolinastudy coordinator listed
Recruiting
Re:Cognition Health
Chicago, Illinoisstudy coordinator listed
Recruiting
Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.
Study leadership
- Amit Ray, MD · STUDY_DIRECTOR · Harmony Biosciences Management, Inc.
Who to contact
Opens a ready-to-send draft in your own email app — review before sending.
Want this trial checked against your situation?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Inclusion
What this trial measures
- Percent Change in CMMS-28From Baseline Period up to 16 weeks
Percent change in CMMS-28 from the Baseline Period through the end of the DB Period