Home / TAK-935-3003
TAK-935-3003
Recruiting

A Study of Soticlestat as an Add-on Therapy in Children and Adults With Dravet Syndrome or Lennox-Gastaut 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 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.

US
JP
CN
17+
Interventional Phase 3 clinical trial.

At a glance

What medical conditions are being studied?

Dravet Syndrome (DS)
Lennox-Gastaut Syndrome (LGS)

What is the clinical trial testing?

Soticlestat

How many participants are being enrolled?

400

Are placebos part of the clinical trial?

Yes

When is the clinical trial being conducted?

Mar 2022 - May 2026

How long is participation in the clinical trial?

Participants will be in the study for about 4 years.

Key requirements

Sexes

All

Age

2-56 years

Healthy volunteers?

No

Entry 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.

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