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

NCT05163314 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 352

Last updated 2025-10-08

No results posted yet for this study

Summary

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.

Conditions

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

Interventions

DRUG

Soticlestat

Soticlestat mini-tablets or tablets

Sponsors & Collaborators

Principal Investigators

  • Study Director · Takeda

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2022-03-04
Primary Completion
2025-09-24
Completion
2025-09-24
FDA Drug
Yes

Countries

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

Study Locations

More Related Trials

Entities

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 NCT05163314 on ClinicalTrials.gov