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

Completed · Phase 3 · Has a placebo group

Conditions studied: Lennox Gastaut Syndrome (LGS)

In brief

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.

Key facts

Study ID

NCT04938427

Run by

Takeda

People needed

270

Starts

2021-11-08

Expected to finish

2024-01-25

Last updated by the study team

2024-08-21

Who can join

Age: 2 and older, up to 55. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Has documented clinical diagnosis of LGS.
• Has had ≥8 MMD seizures each month in the 3 months prior to Screening based on the historical information and has had ≥8 MMD seizures per 28 days during the 4 to 6 week prospective Baseline Period.
• Weighs ≥10 kg at the Screening Visit (Visit 1).
• Failure to control seizures despite appropriate trials of at least 1 ASM based on historical information, and is currently on an antiseizure therapy or other treatment options considered as standard of care (SOC).
• Artisanal cannabidiols are allowed at a stable dose for at least 4 weeks before the screening visit (Visit 1); the dosing regimen and manufacturer should remain constant throughout the study. (Artisanal cannabidiols will not be counted as ASMs.)
• Currently taking 0 to 3 ASMs at stable doses for at least 4 weeks before the Screening Visit (Visit 1); Fenfluramine and cannabidiol (Epidiolex) are allowed where available and counted as an ASM. ASM dosing regimen must remain constant throughout the study.

You may not qualify if…

• Admitted to a medical facility and intubated for treatment of status epilepticus 2 or more times in the 3 months immediately before Screening (Visit 1). For the purpose of this exclusion criterion, status is defined as continuous seizure activity lasting longer than 5 minutes or repeated seizures without return to Baseline in between seizures.
• 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.
• Considered by the investigator to be at imminent risk of suicide or injury to self, others, or property, or the participant has attempted suicide within 12 months before the Screening Visit (Visit 1). Participants who have positive answers on item numbers 4 or 5 on the Columbia suicide severity rating scale (C-SSRS) before dosing (Visit 2) 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
• Children's Hospital Colorado. — Denver, Colorado, United States
• Pediatric Neurology PA — Winter Park, Florida, United States
• Clinical Integrative Research Center of Atlanta — Atlanta, 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 — Roseville, Minnesota, United States
• Institute of Neurology and Neurosurgery at Saint Barnabas, LLC — Livingston, New Jersey, United States
• Premier Healthcare Inc. — New York, New York, United States
• NYU Comprehensive Epilepsy Center — New York, New York, United States
• Northwell Health Physician Partners - Neurology at Lenox Hill — New York, New York, 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
• Seattle Children's Hospital — Seattle, Washington, United States
• MultiCare Institute for Research & Innovation (Tacoma) — Tacoma, Washington, United States
• Sydney Children's Hospital — Randwick, New South Wales, Australia
• Phoenix Childrens Hospital — Phoenix, Arizona, United States

Full record on ClinicalTrials.gov

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