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

Stopped early · Phase 3

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

In brief

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.

Key facts

Study ID

NCT05163314

Run by

Takeda

People needed

352

Starts

2022-03-04

Expected to finish

2025-09-24

Last updated by the study team

2026-06-09

Who can join

Age: 2 and older, up to 56. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Participant must have:
• Been previously enrolled in a phase 3 soticlestat clinical study.

You may not qualify if…

• Unstable, clinically significant neurologic (other than the disease being studied), psychiatric, cardiovascular, ophthalmologic, pulmonary, hepatic, renal, metabolic, gastrointestinal, urologic, immunologic, hematopoietic, endocrine disease, malignancy including progressive tumors, or other abnormality that may impact the ability to participate in the study or that may potentially confound the study results. It is the responsibility of the investigator to assess the clinical significance; however, consultation with the medical monitor may be warranted.
• Abnormal and clinically significant ECG abnormality at Visit 1 including QT interval with Fridericia correction method (QTcF) >450 milliseconds (ms) confirmed with a repeat ECG using manual measurement of QTcF.
• Participant is considered by the investigator to be at imminent risk of suicide or injury to self, others, or property. Participants who have positive answers on item numbers 4 or 5 on the CSSRS before dosing are excluded. This scale will only be administered to participants aged ≥6 years.

Where it is running

• Center For Neurosciences — Tucson, Arizona, United States
• David Geffen School of Medicine at UCLA — Los Angeles, California, United States
• University of California Benioff Children's Hospital — San Francisco, California, United States
• Colorado Children's Hospital — Denver, Colorado, United States
• Pediatric Neurology PA — Winter Park, Florida, United States
• Clinical Integrative Research Center of Atlanta — Atlanta, Georgia, United States
• Sunrise Pediatric Neurology — Marietta, Georgia, United States
• University of Iowa Hospitals & Clinics - (CRS) — Iowa City, Iowa, United States
• Midatlantic Epilepsy and Sleep Center — Bethesda, Maryland, United States
• Minnesota Epilepsy Group PA — Saint Paul, Minnesota, United States
• Institute of Neurology and Neurosurgery at Saint Barnabas, LLC — Livingston, New Jersey, United States
• Boston Children's Health Physicians (BCHP) — New York, New York, United States
• Northwell Health Physician Partners - Neurology at Lenox Hill — New York, New York, United States
• NYU Comprehensive Epilepsy Center — New York, New York, United States
• Bethesda Gyermekkorhaz — Budapest, Hungary
• University of Toledo — Toledo, Ohio, United States
• Oregon Health and Science University — Portland, Oregon, United States
• Children's Hospital of Philadelphia — Philadelphia, Pennsylvania, United States
• Thomas Jefferson University — Philadelphia, Pennsylvania, United States
• St. Christopher's Hospital for Children — Philadelphia, Pennsylvania, United States
• WellSpan Oncology Research — York, Pennsylvania, United States
• Medical University of South Carolina Children Hospital - PIN — Charleston, South Carolina, United States
• Cook Children's Medical Center - Jane and John Justin Neurosciences Center — Fort Worth, Texas, United States
• University of Utah - Primary Children's Hospital - PPDS — Salt Lake City, Utah, United States
• Phoenix Childrens Hospital — Phoenix, Arizona, United States

Full record on ClinicalTrials.gov

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