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Can a new drug curb seizures in children with severe epilepsy?

NCT ID NCT03650452

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 This study
The trial has finished. Results may not be published yet.
Stopped early
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This status has not been confirmed recently, so it may be out of date.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 Sep 14, 2026 · Last updated Sep 15, 2026 · Updated 1 time

Summary

Researchers are testing an experimental drug called TAK-935 in children aged 2 to 17 with Dravet syndrome or Lennox-Gastaut syndrome, two severe forms of epilepsy that often resist treatment. The trial compares TAK-935 added to standard anti-seizure medications against a placebo to see if it reduces how often seizures occur. Participants must have tried at least two anti-seizure drugs without becoming seizure-free. The study measures changes in seizure frequency over a maintenance period.

What this could mean

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

Active substance
TAK-935, an experimental drug added to standard anti-seizure medications
What this could lead to
If it works, TAK-935 could become a new add-on treatment option for children with hard-to-control seizures from Dravet or Lennox-Gastaut syndrome.
What could go wrong
This is a mid-stage trial, so the drug may not reduce seizures more than placebo, and it could cause side effects that outweigh any benefit. Results in children may not apply to adults.

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

141 people

The number who actually took part.

Started

Aug 2018

Finished

Jul 2020

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 to 17 years

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. Male and female participants aged greater than or equal to (\>=) 2 and less than or equal to (\<=) 17 years 2. Clinical diagnosis of DS or LGS 3. Weight of \>=10 kilogram (kg) at the Screening visit 4. Currently taking 1 to 4 anti-epileptic drugs (AEDs) at a stable dose 5. Failed to become and remain seizure free with trials of at least 2 AEDs Exclusion Criteria: 1. Has been admitted to a medical facility and intubated for treatment of status epilepticus 2 or more times in the 3 months immediately prior to the screening visit 2. Non-epileptic events that cannot be reliably distinguished from epileptic seizures 3. Participation in a clinical study involving another study drug in the previous month

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Conditions

The condition(s) this trial relates to.

brain disorder brain hypoxia - ischemia central nervous system disorder cerebral cortical dysplasia developmental and epileptic encephalopathy, 2 Dravet syndrome Epilepsies, Myoclonic epilepsy Lennox-Gastaut syndrome nervous system disorder Spasms, Infantile tuberous sclerosis visual epilepsy

As listed by the trial registrant

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

Dravet syndrome Epilepsy Lennox Gastaut syndrome

Contacts and locations

Locations

  • Ann and Robert H Lurie Childrens Hospital of Chicago

    Chicago, Illinois, 60611, United States

  • Austin Hospital

    Heidelberg West, Victoria, 3081, Australia

  • Beijing Children's Hospital,Capital Medical University

    Beijing, 100069, China

  • Bnai Zion Medical Center

    Haifa, 31048, Israel

  • Capital Medical University (CMU) - Beijing Children's Hospital

    Beijing, 100045, China

  • 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, 1649-035, Portugal

  • Centrum Medyczne Plejady

    Krakow, 30-363, Poland

  • Children's Hospital Los Angeles

    Los Angeles, California, 90027, United States

  • Children's Hospital at Saint Peter's University Hospital

    New Brunswick, New Jersey, 08901, United States

  • Children's Hospital of Fudan University

    Shanghai, 201102, China

  • Clinica Universidad Navarra

    Pamplona, Navarre, 31008, Spain

  • Colorado Children's Hospital

    Aurora, Colorado, 80045, United States

  • Columbia University Medical Center

    New York, New York, 10032, United States

  • Cook Children's Medical Center

    Fort Worth, Texas, 76104, United States

  • Edith Wolfson Medical Center

    Holon, 58100, Israel

  • Hadassah Medical Center

    Jerusalem, 91120, Israel

  • Hospital For Sick Children

    Toronto, Ontario, M5G 1X8, Canada

  • Hospital Ruber Internacional

    Madrid, 28034, Spain

  • Hospital Universitari i Politecnic La Fe de Valencia

    Valencia, 46026, Spain

  • Hospital Vithas La Salud

    Granada, 18008, Spain

  • Instytut Pomnik Centrum Zdrowia Dziecka

    Warsaw, 04-730, Poland

  • Largo da Maternidade de Julio DinisCentro Materno Infantil do Norte

    Porto, 4050-651, Portugal

  • Mayo Clinic - PPDS

    Rochester, Minnesota, 55905, United States

  • Medical University of South Carolina

    Charleston, South Carolina, 29425, United States

  • Monash Children's Hospital

    Clayton, Victoria, 3168, Australia

  • NZOZ Centrum Neurologii Dzieciecej i Leczenia Padaczki

    Kielce, Świętokrzyskie Voivodeship, 25-316, Poland

  • Nicklaus Children's Hospital

    Miami, Florida, 33155, United States

  • Northeast Regional Epilepsy Group

    Hackensack, New Jersey, 07601, United States

  • Pediatric Neurology PA

    Orlando, Florida, 32819, United States

  • Peking University First Hospital

    Beijing, 100034, China

  • Phoenix Children's Hospital

    Phoenix, Arizona, 85016, United States

  • Rare Disease Research, LLC

    Atlanta, Georgia, 30318, United States

  • Samodzielny Publiczny Dzieciecy Szpital Kliniczny w Warszawie

    Warsaw, 02-091, Poland

  • Schneider Childrens Medical Center of Israel

    Petah Tikva, 49202, Israel

  • Sheba Medical Center-PPDS

    Tel Litwinsky, Ramat Gan, 52621, Israel

  • Shenzhen Children's Hospital

    Shenzhen, 518026, China

  • Soroka University Medical Centre

    Bear Sheva, 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

    Tel Aviv, 64239, Israel

  • Uniwersyteckie Centrum Kliniczne - PPDS

    Gdansk, Pomeranian Voivodeship, 80-211, Poland

  • Wake Forest Baptist Medical Center

    Winston-Salem, North Carolina, 27157, United States

  • Xiangya Hospital Central South University

    Changsha, 410078, China

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