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Can a new Add-On drug tame seizures in dravet syndrome?

NCT ID NCT04940624

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 04, 2026 · Last updated Sep 04, 2026

Summary

This phase 3 trial tests whether soticlestat, an experimental oral drug, can reduce convulsive seizures in children and young adults with Dravet syndrome, a severe form of epilepsy. Participants continue their standard antiseizure therapy and also receive either soticlestat or a placebo for 16 weeks. Researchers measure the change in seizure frequency during the treatment period and the maintenance phase. The goal is to see if adding soticlestat helps control seizures better than standard care alone.

What this could mean

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

Active substance
soticlestat (also known as TAK-935), an experimental oral drug taken as an add-on to standard antiseizure therapy
What this could lead to
If it works, soticlestat could become a new add-on treatment to help reduce the number of convulsive seizures in people with Dravet syndrome.
What could go wrong
This is a phase 3 trial, but success is not guaranteed. The drug may not reduce seizures enough, and side effects are possible. Results will need confirmation in this larger study.

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 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

144 people

The number who actually took part.

Started

Oct 2021

Finished

Apr 2024

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 21 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. Has documented clinical diagnosis of DS. 2. Had ≥12 convulsive seizures over 12 weeks before screening based on the historical information and has had ≥4 convulsive seizures per 28 days during the 4- to 6-week prospective baseline period. 3. Weighs ≥10 kg at the screening visit (Visit 1). 4. 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 SOC. 5. 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.). 6. Currently taking 0 to 4 ASMs at stable doses for at least 4 weeks before the screening visit (Visit 1); benzodiazepines used chronically (daily) to treat seizures are considered ASMs. Fenfluramine and cannabidiol (Epidiolex) are allowed where available and should be counted as an ASM. ASM dosing regimen must remain constant throughout the study. Exclusion Criteria: 1\. 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.

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Conditions

The condition(s) this trial relates to.

Dravet syndrome Epilepsies, Myoclonic

As listed by the trial registrant

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

Dravet syndrome (DS)

Contacts and locations

Locations

  • ASST di Pavia - Fondazione Istituto Neurologico Mondino IRCCS

    Pavia, Lombardy, 27100, Italy

  • Aichi Medical University Hospital

    Nagakute-Shi, Aiti, 480-1195, Japan

  • Alberta Childrens Hospital

    Calgary, Alberta, T3B 6A8, Canada

  • Attikon University General Hospital

    Chaïdári, Attica, 124 62, Greece

  • Azienda Ospedaliero Universitaria A Meyer - INCIPIT - PIN

    Florence, Tuscany, 50139, Italy

  • Beijing Children's Hospital,Capital Medical University

    Beijing, Beijing Municipality, 100045, China

  • CNPE Clinical Hospital Psychiatry of the Executive Body of the Kyiv City Council KCSA

    Kyiv, 4080, Ukraine

  • Centrum Medyczne Plejady

    Krakow, Lesser Poland Voivodeship, 30-363, Poland

  • Child and Family Research Institute

    Vancouver, British Columbia, V5Z 4H4, Canada

  • Children's Hospital of Chongqing Medical University

    Chongqing, Chongqing Municipality, 400014, China

  • Children's Hospital of Fudan University

    Shanghai, Shanghai Municipality, 201102, China

  • Children's Hospital of Shanghai

    Shanghai, Shanghai Municipality, 200040, China

  • Childrens University Hospital

    Riga, LV-1004, Latvia

  • Clinic for Neurology and Psychiatry for Children and Youth

    Belgrade, 11000, Serbia

  • Clinical Integrative Research Center of Atlanta

    Atlanta, Georgia, 30328, United States

  • Communal Non-commercial Enterprise Iv-Frank Regional Childrens Clinical Hosp of Iv-Frank RC

    Ivano-Frankivsk, 76018, Ukraine

  • Communal Non-profit Enterprise City Childrens Clinical Hospital #6 of DCC

    Dnipro, Dnipropetrovsk Oblast, 49101, Ukraine

  • David Geffen School of Medicine at UCLA

    Los Angeles, California, 90095-3075, United States

  • Fondazione Policlinico Universitario A Gemelli

    Rome, Lazio, 168, Italy

  • Hokkaido University Hospital

    Chuo-Ku, Tokyo, 104-0045, Japan

  • Hopital Necker - Enfants Malades

    Paris, 75015, France

  • Hopital Robert Debre

    Paris, 75019, France

  • Hopitaux de La Timone

    Marseille, 13386, France

  • Hospital For Sick Children

    Toronto, Ontario, M5G 1X8, Canada

  • Hospital Regional Universitario de Malaga Hospital General

    Málaga, 29010, Spain

  • Hospital Sao Lucas Da Pontificia Universidade Catolica Do Rio Grande Do Sul (PUCRS)

    Porto Alegre, Rio Grande do Sul, 90610-000, Brazil

  • Hospital Universitari i Politecnic La Fe de Valencia

    Valencia, 46026, Spain

  • Hospital Universitario Vall d'Hebron - PPDS

    Barcelona, 8035, Spain

  • IRCCS Ospedale Pediatrico Bambino Gesu - INCIPIT - PIN

    Rome, Lazio, 164, Italy

  • Instituto de Neurologia de Curitiba (INC)

    Curitiba, Paraná, 81210-310, Brazil

  • Kempenhaeghe - PPDS

    Heeze, North Brabant, 5591 VE, Netherlands

  • Klinikum der Johann-Wolfgang Goethe-Universitat

    Frankfurt am Main, Hesse, 60528, Germany

  • Krankenhaus Mara gGmbH - Epilepsiezentrum Bethel

    Bielefeld, North Rhine-Westphalia, 33617, Germany

  • Krasnoyarsk State Medical University n.a. V.F. Voyno-Ysenetskiy

    Krasnoyarsk, 660022, Russia

  • Kumamoto-Ezuko Medical Center for The Severely Disabled

    Kumamoto, Kumamoto, 862-0947, Japan

  • Medical University of South Carolina

    Charleston, South Carolina, 29403, United States

  • Mother and Child Health Care Institute of Serbia Dr Vukan Cupic

    Belgrade, 11000, Serbia

  • Multicare Health System - Mary Bridge Pediatrics

    Tacoma, Washington, 98405, United States

  • NYU Comprehensive Epilepsy Center

    New York, New York, 10016, United States

  • National Center of Neurology and Psychiatry

    Kodaira-Shi, Tokyo, 187-0031, Japan

  • National Hospital Organization Nagasaki Medical Center

    Omura-Shi, Nagasaki, 856-0835, Japan

  • National Hospital Organization Nishi-Niigata Chuo National Hospital

    Niigata, Niigata, 950-2074, Japan

  • National Hospital Organization Shizuoka Institute of Epilepsy and Neurological Disorders

    Shizuoka, Shizuoka, 420-0953, Japan

  • Neurosphera SP. Z O.O

    Warsaw, Masovian Voivodeship, 02-952, Poland

  • Orszagos Mentalis, Ideggyogyaszati es Idegsebeszeti Intezet

    Budapest, 1145, Hungary

  • Osaka City General Hospital

    Osaka, Osaka, 534-0021, Japan

  • Osaka University Hospital

    Suita-Shi, Osaka, 565-0871, Japan

  • Peking University First Hospital

    Beijing, Beijing Municipality, 100034, China

  • Phoenix Childrens Hospital

    Phoenix, Arizona, 85016-7710, United States

  • Queensland Childrens Hospital

    South Brisbane, Queensland, 4101, Australia

  • Russian National Research Medical University n.a. N.I.Pirogov

    Moscow, Moscow, 117437, Russia

  • Schon Klinik Vogtareuth

    Vogtareuth, Bavaria, 83569, Germany

  • Seattle Children's Hospital

    Seattle, Washington, 98105-3901, United States

  • Shenzhen Children's Hospital

    Shenzhen, Guangdong, 518026, China

  • Stichting Epilepsie Instellingen Nederland

    Zwolle, Overijssel, 8025 BV, Netherlands

  • Szpital Kliniczny im. H.Swiecickiego Uniwersytetu Medycznego im. Karola Marcinkowskiego w Poznaniu

    Poznan, 60-355, Poland

  • The First Hospital of Jilin University

    Changchun, Jilin, 130021, China

  • The Second Affiliated Hospital of Guangzhou Medical University

    Guangzhou, Guangdong, 510260, China

  • Universidade de Sao Paulo

    São Paulo, 04039-032, Brazil

  • University Clinical Center Nis

    Niš, 18 000, Serbia

  • University of California Benioff Children's Hospital

    San Francisco, California, 94143-2350, United States

  • University of Iowa Hospitals & Clinics - (CRS)

    Iowa City, Iowa, 52242-1009, United States

  • University of Toledo

    Toledo, Ohio, 43606-3818, United States

  • Uniwersyteckie Centrum Kliniczne

    Gdansk, 80-952, Poland

  • Wuhan Childrens hospital

    Wuhan, Hubei, 430010, China

  • Xiangya Hospital Central South University

    Changsha, Hunan, 410008, China

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