New drug shows promise for Tough-to-Treat seizures in kids

NCT ID NCT03635073

Terminated Disease control Sponsor: Takeda Source: ClinicalTrials.gov ↗

First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study looked at the long-term safety of soticlestat, an experimental drug, in children and adults with severe forms of epilepsy like Dravet syndrome and Lennox-Gastaut syndrome. Participants took soticlestat twice a day along with their usual seizure medicines. The study was terminated early, but researchers were checking for side effects and changes in behavior and seizure frequency.

What this could mean

Our plain-language read of the trial. This is informational only — not medical advice or a prediction.

Active substance: soticlestat (TAK-935)
What this could lead to: If successful, soticlestat could offer a new long-term add-on treatment option to help control seizures in children with severe epilepsies.
What could go wrong: This study was terminated early, so results may be incomplete. It is a phase 2 trial, meaning it is still early-stage and focused on safety, not proof of effectiveness. Side effects are possible.

This is an AI summary of the original study and may miss details. Read our disclaimer.

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Conditions

The condition(s) this trial relates to.

15q11q13 microduplication syndrome CDKL5 disorder developmental and epileptic encephalopathy Dravet syndrome Epilepsies, Myoclonic epilepsy Lennox-Gastaut syndrome

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

DRAVET SYNDROME (DS) EPILEPSY LENNOX GASTAUT SYNDROME (LGS)

Contacts and locations

Locations

Ann and Robert H Lurie Childrens Hospital of Chicago

Chicago, Illinois, 60611, United States
Austin Hospital

Heidelberg, Victoria, 3084, Australia
Austin Hospital

Heidelberg West, Victoria, 3081, Australia
Beijing Children's Hospital,Capital Medical University

Beijing, 100045, China
Beijing Children's Hospital,Capital Medical University

Beijing, 100069, China
Bluegrass Epilepsy Research LLC

Lexington, Kentucky, 40504, United States
Bnai Zion Medical Center

Haifa, 31048, Israel
Boston Children's Hospital

Boston, Massachusetts, 02115, United States
Center for Rare Neurological Diseases

Norcross, Georgia, 30093, United States
Centro Hospitalar Lisboa Central- Hospital Dona Estefania

Lisbon, 1169-045, Portugal
Centro Hospitalar Lisboa Norte, E.P.E. Hospital de Santa Maria

Lisbon, 1600-035, Portugal
Centro Hospitalar Lisboa Norte, E.P.E. Hospital de Santa Maria

Lisbon, 1649-035, Portugal
Centrum Medyczne Plejady

Krakow, 30-363, Poland
Children's Hospital at Saint Peter's University Hospital

New Brunswick, New Jersey, 08901, United States
Children's Hospital of Fudan University

Shanghai, Shanghai Municipality, 201102, China
Clinica Universidad Navarra

Pamplona, Navarre, 31008, Spain
Colorado Children's Hospital

Aurora, Colorado, 80045-7106, United States
Colorado Children's Hospital

Aurora, Colorado, 80045, United States
Columbia University Medical Center - PIN

New York, New York, 10032, United States
Cook Children's Medical Center - Jane and John Justin Neurosciences Center

Fort Worth, Texas, 76104, United States
David Geffen School of Medicine at UCLA

Los Angeles, California, 900095-1752, United States
David Geffen School of Medicine at UCLA

Los Angeles, California, 90095-8358, United States
Edith Wolfson Medical Center

Holon, 58100, Israel
Hospital For Sick Children

Toronto, Ontario, M5G 1X8, Canada
Hospital Ruber Internacional (Grupo Quironsalud)

Madrid, Madrid, Communidad Delaware, 28034, Spain
Hospital Ruber Internacional (Grupo Quironsalud)

Madrid, 28034, Spain
Hospital Universitari i Politecnic La Fe de Valencia

Valencia, 46026, Spain
Hospital Vithas La Salud

Granada, 18008, Spain
Max Benzaquen, M.D., PC

Chesterfield, Missouri, 63017, United States
Mayo Clinic - PIN

Rochester, Minnesota, 55905, United States
Medical University of South Carolina Childrens Hospital - PIN

Charleston, South Carolina, 29425, United States
Medsol Clinical Research Center Inc

Port Charlotte, Florida, 33952, United States
Medsol Clinical Research Center Inc

Port Charlotte, Florida, 33980, United States
Minnesota Epilepsy Group PA

Saint Paul, Minnesota, 55102, United States
Monash Children's Hospital

Clayton, Victoria, 3168, Australia
NYU - Ambulatory Care Center (ACC)

New York, New York, 10016, United States
NZOZ Centrum Neurologii Dzieciecej i Leczenia Padaczki

Kielce, Świętokrzyskie Voivodeship, 25-316, Poland
Nicklaus Children's Hospital

Miami, Florida, 33155-3009, United States
Nicklaus Children's Hospital

Miami, Florida, 33155, United States
Northeast Regional Epilepsy Group

Hackensack, New Jersey, 07601-1974, United States
Pediatric Neurology PA

Winter Park, Florida, 32789, United States
Peking University First Hospital

Beijing, 100034, China
Rare Disease Research, LLC

Atlanta, Georgia, 30318, United States
Rare Disease Research, LLC

Atlanta, Georgia, 30322, United States
Samodzielny Publiczny Dzieciecy Szpital Kliniczny w Warszawie

Warsaw, 02-091, Poland
Schneider Children's Medical Center of Israel - Petah Tikvah - PIN

Petah Tikva, 49100, Israel
Sheba Medical Center - PPDS

Ramat Gan, 52621, Israel
Sheba Medical Center - PPDS

Ramat Gan, 5265601, Israel
Shenzhen Children's Hospital

Shenzhen, Guangdong, 518026, China
Soroka University Medical Centre

Beersheba, 84101, Israel
Szpital Kliniczny im. H.Swiecickiego Uniwersytetu Medycznego im. Karola Marcinkowskiego w Poznaniu

Poznan, Greater Poland Voivodeship, 60-355, Poland
Tel Aviv Sourasky Medical Center PPDS

Tel Aviv, Tel Aviv, 64239, Israel
Tel Aviv Sourasky Medical Center PPDS

Tel Aviv, 64239, Israel
University of South Florida

Tampa, Florida, 33606, United States
Uniwersyteckie Centrum Kliniczne

Gdansk, Pomeranian Voivodeship, 80-952, Poland
Wake Forest Baptist Medical Center - PPDS

Winston-Salem, North Carolina, 27157, United States
Xenosciences Inc

Phoenix, Arizona, 85004, United States
Xiangya Hospital Central South University

Changsha, 410008, China
Xiangya Hospital of Central South University

Changsha, 410008, China

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