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

NCT ID NCT03635073

Disease control Sponsor: Takeda Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Sep 04, 2026 · Updated 2 times

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.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

156 people

The number who actually took part.

Started

Jul 2018

Finished

Jul 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

2 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. 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. 2. In the opinion of the investigator, the participant has the potential to benefit from the administration of soticlestat Exclusion Criteria: 1. Clinically significant disease, that, in the investigator's opinion, precludes study participation. 2. 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). 3. 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. 4. 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.

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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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