A Study of Soticlestat as an Add-on Therapy in Children and Adults With Dravet Syndrome or Lennox-Gastaut Syndrome

Phase 3 Terminated NCT05163314

Summary

The main aim of the study is to learn if soticlestat, when given as an add-on therapy, reduces the number of seizures in children and adults with Dravet Syndrome (DS) or Lennox-Gastaut Syndrome (LGS). Participants will receive their standard anti-seizure therapy, plus tablets of soticlestat. There will be scheduled visits and follow-up phone calls throughout the study.

Number of Participants With At Least One Treatment Emergent Adverse Event (TEAE)

Up to end of study (approximately 3.6 years) · Participants

Number of Participants in Each Category of the Columbia-Suicide Severity Rating Scale (C-SSRS) Over Time

At first visit post-baseline (Visit 1 [V1], Day 1 of the current study), Week 13 (V4), Week 26 (V5), Week 52 (V7), Week 78 (V9), Week104 (v11), Week 130 (V12) and Week 156 (V13) · Participants

Change From Baseline in Body Weight for All Age Groups

From Baseline to Week 104 · kilogram (kg)

Open in BENITIONS View on ClinicalTrials.gov

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