About the Study
This study is designed to evaluate the safety and potential effectiveness of clemizole hydrochloride, an investigational oral medication, in reducing major motor seizures in individuals with LGS. Participants who qualify will continue their current antiseizure medications while taking either the investigational medication or placebo during the initial study phase.
Who may qualify:
- Are 2 to 55 years old
- Have a confirmed diagnosis of Lennox–Gastaut Syndrome (LGS), including:
- Major motor seizures that can be counted
- EEG features consistent with LGS
- Abnormal cognitive development
- Seizure onset at age ≤11 years
- Have had at least 4 countable seizures per month in the two months before screening, including tonic or tonic/atonic seizures
- Experience at least 4 major motor seizures during the initial 28-day observation period
- Have tried one or more antiseizure medications without adequate seizure control
- Are taking 4 or fewer antiseizure medications, stable for ≥30 days
- Can maintain a daily seizure diary with the help of a parent/caregiver/LAR
- For females who can become pregnant:
- Have negative pregnancy tests
- Agree to nonhormonal contraception or abstinence during the study and for 15 days afterward