About this trial
Last updated a year ago
Study ID
TAK-935-3002
Status
Completed
Type
Interventional
Phase
Phase 3
Placebo
Yes
Accepting
2 to 55 Years
All
Not accepting
Healthy Volunteers
Trial Timing
Ended a year ago
What is this trial about?
The aims of the study are:
- to learn if soticlestat, when given as add-on therapy, reduces the number of major
motor drop seizures in children, teenagers, and adults with Lennox-Gastaut Syndrome.
- to assess the safety profile of soticlestat when given in combination with other
therapies.
Participants will receive their standard antiseizure therapy, plus either tablets of
soticlestat or placebo. A placebo looks just like soticlestat but will not have any
medicine in it. Participants will take soticlestat or placebo for 16 weeks, followed by a
gradual dose reduction for 1 week. Then, participants will be followed up for 2 weeks.
What are the participation requirements?
Inclusion Criteria
Boys, girls, men, and women can take part.
Must be from 2 to 35 years old.
Must have a clinical diagnosis of Lennox-Gastaut Syndrome.
Additional entry criteria will be discussed with the study doctor.