TAK-935-3001
Completed
A Study of Soticlestat as an Add-on Therapy in Children and Young Adults With Dravet Syndrome
About this clinical trial
The main aim of the study is to learn if soticlestat, when given as an add-on therapy, reduces the number of convulsive seizures in children and young adults with DS. Participants will receive their standard antiseizure therapy, plus either a tablet of soticlestat or placebo for 16 weeks. A placebo looks just like soticlestat but will not have any medicine in it. Participants may continue treatment in an extension study, based on the extension study's entry criteria. Those that want to stop treatment will have a gradual dose reduction during 1 week and then be followed up for 2 weeks.
At a glance
What medical conditions were being studied?
Dravet Syndrome (DS)
Epilepsy
What was the clinical trial testing?
Placebo, Soticlestat
How many participants were enrolled?
144
Were placebos part of the clinical trial?
Yes
When was the clinical trial conducted?
Oct 2021 - Apr 2024
How long was participation in the clinical trial?
Each participant will be in this study for about 25 weeks.
Key requirements
Sexes
All
Age
2-21 years
Healthy volunteers?
No
Entry criteria
Boys, girls, men, and women can take part.
Must be from 2 to 21 years old.
Must have a diagnosis of Dravet Syndrome.
Must have had 4 or more convulsive seizures every month for the last 3 months.
Must weigh 10 kilograms (kg) or more.
Must be receiving anti-seizure therapy.
Additional entry criteria will be discussed with the study doctor.
