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A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy, Safety, and Tolerability of Soticlestat as Adjunctive Therapy in Pediatric and Adult Subjects With Lennox-Gastaut Syndrome (LGS)

TAK-935-3002_LGS

  • Condition(s): Other
  • Phase: III
  • Clinicaltrials.gov ID: NCT04938427

What is the goal of the study?

This is a phase 3, global, multicenter,1:1 randomized, double-blind, placebo-controlled, parallel-group study to evaluate the efficacy, safety, and tolerability of soticlestat as an adjunctive therapy in pediatric and adult subjects with Lennox-Gastaut Syndrome (LGS). The treatment period is 16 weeks. The total duration of the study is approximately 25 weeks for subjects who complete the study and choose not to roll over to the open-label extension (OLE) study. For those who roll over to the OLE study, the study duration is 3 weeks shorter.

Who can participate in the study?

Everyone

Study Team: