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

NCT04938427 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 270

Last updated 2024-08-21

Study results available
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Summary

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.

Conditions

  • Lennox Gastaut Syndrome (LGS)

Interventions

DRUG

Placebo

Soticlestat placebo-matching mini-tablets or tablets.

DRUG

Soticlestat

Soticlestat mini-tablets or tablets.

Sponsors & Collaborators

Principal Investigators

  • Medical Director · Takeda

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
2 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-11-08
Primary Completion
2024-01-25
Completion
2024-01-25
FDA Drug
Yes

Countries

  • United States
  • Australia
  • Belgium
  • Canada
  • China
  • France
  • Germany
  • Greece
  • Hungary
  • Italy
  • Japan
  • Latvia
  • Netherlands
  • Poland
  • Russia
  • Serbia
  • Spain
  • Ukraine

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04938427 on ClinicalTrials.gov