A Study of Soticlestat in Adults and Children With Rare Epilepsies

Stopped early · Phase 2

Conditions studied: Epilepsy, Dravet Syndrome (DS), Lennox-Gastaut Syndrome (LGS)

In brief

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.

Key facts

Study ID

NCT03635073

Run by

Takeda

People needed

156

Starts

2018-07-19

Expected to finish

2025-07-30

Last updated by the study team

2026-03-19

Who can join

Age: 2 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Participants must have participated in a previous soticlestat study and meet one of the following conditions:
• Successfully completed a soticlestat clinical study.
• Received at least 10 weeks of treatment with the study drug in an antecedent placebo-controlled blinded soticlestat clinical study and the participant did not have a serious or severe AE that, in the investigator's or sponsor's opinion, was related to the study drug and would make it unsafe for the participant to continue receiving the study drug.
• In the opinion of the investigator, the participant has the potential to benefit from the administration of soticlestat

You may not qualify if…

• Clinically significant disease, that, in the investigator's opinion, precludes study participation.
• Enrollment in any other clinical trial involving an investigational drug, device, or treatment in the past 90 days (with the exception of an antecedent study involving Soticlestat).
• Participant is currently pregnant or breastfeeding or is planning to become pregnant during the study or within 30 days of the last study drug administration.
• Suicide attempt within the last year, at significant risk of suicide (either in the opinion of the investigator or defined as 'yes' to suicidal ideation question 4 or 5 on the C-SSRS at Screening) or appearing suicidal per investigator judgment.

Where it is running

• David Geffen School of Medicine at UCLA — Los Angeles, California, United States
• David Geffen School of Medicine at UCLA — Los Angeles, California, United States
• Colorado Children's Hospital — Aurora, Colorado, United States
• Colorado Children's Hospital — Aurora, Colorado, United States
• Nicklaus Children's Hospital — Miami, Florida, United States
• Nicklaus Children's Hospital — Miami, Florida, United States
• Medsol Clinical Research Center Inc — Port Charlotte, Florida, United States
• Medsol Clinical Research Center Inc — Port Charlotte, Florida, United States
• University of South Florida — Tampa, Florida, United States
• Pediatric Neurology PA — Winter Park, Florida, United States
• Rare Disease Research, LLC — Atlanta, Georgia, United States
• Rare Disease Research, LLC — Atlanta, Georgia, United States
• Center for Rare Neurological Diseases — Norcross, Georgia, United States
• Ann and Robert H Lurie Childrens Hospital of Chicago — Chicago, Illinois, United States
• Bluegrass Epilepsy Research LLC — Lexington, Kentucky, United States
• Boston Children's Hospital — Boston, Massachusetts, United States
• Mayo Clinic - PIN — Rochester, Minnesota, United States
• Minnesota Epilepsy Group PA — Saint Paul, Minnesota, United States
• Max Benzaquen, M.D., PC — Chesterfield, Missouri, United States
• Northeast Regional Epilepsy Group — Hackensack, New Jersey, United States
• Children's Hospital at Saint Peter's University Hospital — New Brunswick, New Jersey, United States
• NYU - Ambulatory Care Center (ACC) — New York, New York, United States
• Columbia University Medical Center - PIN — New York, New York, United States
• Wake Forest Baptist Medical Center - PPDS — Winston-Salem, North Carolina, United States
• Xenosciences Inc — Phoenix, Arizona, United States

Full record on ClinicalTrials.gov

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