This is a multicenter, Phase 3, randomized, double-blind, placebo-controlled study designed to evaluate the efficacy and safety of clemizole HCL (EPX-100) as adjunctive therapy in children and adult participants with Lennox-Gastaut syndrome (LGS).
This is a multicenter, Phase 3, randomized, double-blind, placebo-controlled study designed to evaluate the efficacy and safety of clemizole HCl as adjunctive therapy in children and adult participants with LGS. The study will consist of an Observational Period, a Double-Blind (DB) Period, and an optional Open-Label Extension (OLE) Period.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
260
Clemizole HCl will be administered as an oral solution.
Placebo will be administered as an oral solution.
Rare Disease Research
Kissimmee, Florida, United States
RECRUITINGMinnesota Epilepsy Group, P.A.
Roseville, Minnesota, United States
RECRUITINGNeurology Center for Epilepsy and Seizures
Marlboro, New Jersey, United States
RECRUITINGPercent Change in CMMS-28
Percent change in CMMS-28 from the Baseline Period through the end of the DB Period
Time frame: From Baseline Period up to 16 weeks
Proportion of Participants with ≥50% Reduction in CMMS-28
Proportion of participants with ≥50% reduction in CMMS-28 from the Baseline Period through the end of the DB Period
Time frame: From Baseline Period up to 16 weeks
Percent Change in CMMS-28 Seizure-free Days
Percent change in CMMS-28 seizure-free days from the Baseline Period through the end of the DB Period
Time frame: From Baseline Period up to 16 weeks
Clinical Global Impression of Change (CGI-C) Score
CGI-C score at the end of the DB Period
Time frame: Week 16
Caregiver Global Impression of Change (CaGI-C) Score
CaGI-C score at the end of the DB Period
Time frame: Week 16
Caregiver Global Impression of Change in Seizure Intensity/Duration (CaGI-CSID) Score
CaGI-CSID score at the end of the DB Period
Time frame: Week 16
Change in Quality of Life Inventory (QI)-Disability Score
Change in QI-disability score from Baseline to the end of the DB Period
Time frame: From Baseline Period up to 16 weeks
Percent Change per 28 Days in the Number of Seizure Free Days
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On-Site Clinical Solution
Charlotte, North Carolina, United States
RECRUITINGPercent change per 28 days in the number of seizure-free days (based on all seizure types) from the Baseline Period through the end of the DB Period
Time frame: From Baseline Period up to 16 weeks
Percent Change in CMMS-28
Percent change in CMMS-28 from the Baseline Period through the end of the DB Maintenance Phase only
Time frame: From Baseline Period up to 12 weeks
Proportion of Participants with ≥50% Reduction in CMMS-28
Proportion of participants with ≥50% reduction in CMMS-28 from the Baseline Period through the end of the DB Maintenance Phase only
Time frame: From Baseline Period up to 12 weeks
Incidence of Treatment-Emergent Adverse Events (TEAEs)
Incidence of TEAEs will be compared among the treatment groups
Time frame: From the first dose administration of study drug up to end of the study, approximately up to 172 weeks