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A Study of Soticlestat in Adults and Children With Rare Epilepsies

NCT03635073 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 156

Last updated 2026-03-19

Study results available
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Summary

The main aim is to assess the long-term safety and tolerability of soticlestat when used along with other anti-seizure treatment.

Participants will receive soticlestat twice a day. Participants will visit the study clinic every 2-6 months throughout the study.

Study treatments may continue as long as the participant is receiving benefit from it.

Conditions

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

Interventions

DRUG

Soticlestat

Soticlestat tablets or mini-tablets.

Sponsors & Collaborators

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
2 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-07-19
Primary Completion
2025-07-30
Completion
2025-07-30
FDA Drug
Yes

Countries

  • United States
  • Australia
  • Canada
  • China
  • Israel
  • Poland
  • Portugal
  • Spain

Study Locations

More Related Trials

Entities

Diseases
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 NCT03635073 on ClinicalTrials.gov