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TAK-935-3002
Completed

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

Clinicaltrials.gov
#NCT04938427
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About this clinical trial

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.

US
CN
JP
15+
Interventional Phase 3 clinical trial.

At a glance

What medical conditions were being studied?

Epilepsy

What was the clinical trial testing?

Placebo, Soticlestat

How many participants were enrolled?

270

Were placebos part of the clinical trial?

Yes

When was the clinical trial conducted?

Nov 2021 - Jan 2024

How long was participation in the clinical trial?

Participants will be in this study for about 25 weeks.

Key requirements

Sexes

All

Age

2-55 years

Healthy volunteers?

No

Entry 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.

Locations