A Study of Soticlestat as an Add-on Therapy in Children and Adults With Dravet Syndrome or Lennox-Gastaut Syndrome
Sponsored by Takeda
About this trial
Last updated 4 months ago
Study ID
TAK-935-3003
Status
Active, not recruiting
Type
Interventional
Phase
Phase 3
Placebo
Yes
Accepting
2 to 56 Years
All
Not accepting
Healthy Volunteers
Trial Timing
Started 3 years ago
What is this trial about?
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.
What are the participation requirements?
Inclusion Criteria
Boys, girls, men, and women can take part.
Must have received at least 10 weeks of treatment with soticlestat in either TAK-935-3001 or TAK-935-3002 clinical studies.
Additional entry criteria will be discussed with the study doctor.