TAK-935-3002

Completed

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

Clinicaltrials.gov

EudraCT

#2021-002481-40

jRCT

#jRCT2051210073

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.

15+

Interventional Phase 3 clinical trial.

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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.

Sexes

All

Age

2-55 years

Healthy volunteers?

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.

View study results on registries

Clinicaltrials.gov EudraCT

Primary outcome measures

Percent Change From Baseline in Major Motor Drop (MMD) Seizure Frequency Per 28 Days During the Full Treatment Period [Time Frame: Baseline; Full Treatment Period: Weeks 1 to 16]

Percent Change From Baseline in Major Motor Drop (MMD) Seizure Frequency Per 28 Days During the Maintenance Period [Time Frame: Baseline; Maintenance Period: Weeks 5 to 16]

Secondary outcome measures

Percentage of Responders During the Maintenance Period [Time Frame: Maintenance Period: Weeks 5 to 16]

Percentage of Responders During the Full Treatment Period [Time Frame: Full Treatment Period: Weeks 1 to 16]

Percentage of Participants With ≤0%, >0% to ≤25%, >25% to ≤50%, >50% to ≤75%, >75% to ≤100% Reduction in MMD Seizure During the Full Treatment Period [Time Frame: Full Treatment Period: Weeks 1 to 16]

Percentage of Participants With Caregiver Global Impression of Improvement (Care GI-I) Scale Responses as Per the Parent/Caregiver Reported Impression at Week 16 [Time Frame: Week 16]

Percentage of Participants With Clinical Global Impression of Improvement (CGI-I) Scale Responses as Per the Investigator Reported Impression at Week 16 [Time Frame: Week 16]

Percentage of Participants With CGI-I Nonseizure Symptoms Instrument Responses for Each Domain as Per the Investigator Reported Impression at Week 16 [Time Frame: Week 16]

Change From Baseline in Quality of Life Inventory-Disability (QI-Disability) Total Score at Week 16 [Time Frame: Baseline, Week 16]

Percentage of Participants With CGI-I Seizure Intensity and Duration Instrument Responses as Per the Parent/Caregiver Reported Impression at Week 16 [Time Frame: Week 16]

Percent Change From Baseline in Frequency of All Seizures Per 28 Days During the Maintenance Period [Time Frame: Baseline; Maintenance Period: Weeks 5 to 16]

Percent Change From Baseline in Frequency of All Seizures Per 28 Days During the Full Treatment Period [Time Frame: Baseline; Full Treatment Period: Weeks 1 to 16]

Change From Baseline in Percentage of MMD Seizure-free Days During the Full Treatment Period [Time Frame: Baseline up to Week 16]

Longest MMD Seizure-free Interval During the Full Treatment Period [Time Frame: Full Treatment Period: Weeks 1 to 16]

Number of Days When Rescue Antiseizure Medication (ASM) is Used During the Full Treatment Period [Time Frame: Full Treatment Period: Weeks 1 to 16]

Recruiting

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

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

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

About this clinical trial

At a glance