A Phase 3, Prospective, Open-Label, Multisite, Extension of Phase 3 Studies To Assess the Long-Term Safety and Tolerability of Soticlestat as Adjunctive Therapy in Subjects With Dravet Syndrome or Lennox-Gastaut Syndrome (ENDYMION 2)
TAK-935-3003
What is the goal of the study?
This is a multisite, phase 3, open-label extension (OLE) study designed to obtain additional safety and tolerability data related to soticlestat administered long-term in subjects who participated in either of the antecedent phase 3 clinical studies, TAK-935-3001 (subjects with Dravet syndrome [DS]) or TAK-935-3002 (subjects with Lennox-Gastaut syndrome [LGS]). Additional objectives are to assess effectiveness in terms of seizure frequency, non–seizure-related symptoms, impact on quality of life, and the pharmacokinetics (PK) and pharmacodynamics (PD) (concentration of 24S-hydroxycholesterol [24HC]) of soticlestat administration in pediatric and adult subjects with DS or LGS.
Who can participate in the study?
Please contact the study team listed below to learn more.