Lennox Gastaut Syndrome Clinical Trial
Official title:
A 20-Week Multicenter, Randomized, Double-Blind, Placebo-Controlled, Proof of Concept Trial of EPX-100 (Clemizole Hydrochloride) as Adjunctive Therapy in Children With Lennox-Gastaut Syndrome
EPX-100 (Clemizole Hydrochloride) as Adjunctive Therapy in Children With Lennox Gastaut Syndrome. (LGS)
To evaluate the efficacy of EPX-100 orally in divided doses as adjunctive therapy compared with placebo as measured by percent change in the frequency of seizures that result in drops in participants with Lennox-Gastaut Syndrome between the 4-week Observation Phase (Baseline period) and the final 4-week period of the 12-week Maintenance Phase. The 20 week study to include a 4-week Observation Phase (baseline) prior to initiation of study treatment, 4-week Titration Phase, and 12-week Maintenance Phase. At the option of the participant, he/she can continue oral administration of EPX-100 in an Open-Label Extension (OLE) Phase for another 52 weeks after the end of the Maintenance Phase. ;
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