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NCT04938427

PHASE3

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

Sponsor: Takeda

View on ClinicalTrials.gov

Summary

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.

Official title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy, Safety, and Tolerability of Soticlestat as Adjunctive Therapy in Pediatric and Adult Subjects With Lennox-Gastaut Syndrome (LGS)

Key Details

Gender

All

Age Range

2 Years - 55 Years

Study Type

INTERVENTIONAL

Enrollment

270

Start Date

2021-11-08

Completion Date

2024-01-25

Last Updated

2026-09-10

Healthy Volunteers

Conditions

Lennox Gastaut Syndrome (LGS)

Interventions

DRUG

Placebo

Soticlestat placebo-matching mini-tablets or tablets.

DRUG

Soticlestat

Soticlestat mini-tablets or tablets.

Inclusion Criteria: 1. Has documented clinical diagnosis of LGS. 2. 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. 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 standard of care (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 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. Exclusion Criteria: 1. 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. 2. 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. 3. 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.

Locations (98)

Phoenix Childrens Hospital

Phoenix, Arizona, United States

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

Queensland Childrens Hospital

South Brisbane, Queensland, Australia

Austin Hospital

Heidelberg, Victoria, Australia

Alfred Hospital

Melbourne, Victoria, Australia

UZ Antwerpen PIN

Edegem, Antwerpen, Belgium

Centre Neurologique William Lennox

Ottignies-Louvain-la-Neuve, Brabant Wallon, Belgium

Hopital Universitaire des Enfants Reine Fabiola

Brussels, Belgium

Alberta Childrens Hospital

Calgary, Alberta, Canada

Child and Family Research Institute

Vancouver, British Columbia, Canada

Hospital For Sick Children

Toronto, Ontario, Canada

Peking University First Hospital

Beijing, Beijing Municipality, China

Beijing Children's Hospital,Capital Medical University

Beijing, Beijing Municipality, China

Children's Hospital of Chongqing Medical University

Chongqing, Chongqing Municipality, China

The Second Affiliated Hospital of Guangzhou Medical University

Guangzhou, Guangdong, China

Guangzhou Women And Children's Medical Center

Guangzhou, Guangdong, China

Shenzhen Children's Hospital

Shenzhen, Guangdong, China

Wuhan Childrens hospital

Wuhan, Hubei, China

Xiangya Hospital Central South University

Changsha, Hunan, China

Jiangxi Provincial Children's Hospital

Nanchang, Jiangxi, China

The First Hospital of Jilin University

Changchun, Jilin, China

Children's Hospital of Shanghai

Shanghai, Shanghai Municipality, China

Children's Hospital of Fudan University

Shanghai, Shanghai Municipality, China

CHRU Dijon Hopital General

Dijon, Cote-d'Or, France

Hopital Roger Salengro

Lille, Nord, France

Hopitaux de La Timone

Marseille, France

Hopital Necker - Enfants Malades

Paris, France

Hopital Robert Debre

Paris, France

Schon Klinik Vogtareuth

Vogtareuth, Bavaria, Germany

Klinikum der Johann-Wolfgang Goethe-Universitat

Frankfurt am Main, Hesse, Germany

Krankenhaus Mara gGmbH - Epilepsiezentrum Bethel

Bielefeld, North Rhine-Westphalia, Germany

Kleinwachau Sachsisches Epilepsiezentrum Radeberg Gemeinnutzige Gmbh

Radeberg, Sachse, Germany

Attikon University General Hospital

Chaïdári, Attica, Greece

University General Hospital of Larissa

Larissa, Greece

Hippokration Hospital

Thessaloniki, Greece

Pecsi Tudomanyegyetem

Pécs, Baranya, Hungary

Szent Janos Korhaz es Eszak-Budai Egyesitett Korhazak

Budapest, Hungary

Bethesda Gyermekkorhaz

Budapest, Hungary

Orszagos Mentalis, Ideggyogyaszati es Idegsebeszeti Intezet

Budapest, Hungary

Ospedale Bellaria

Bologna, Emilia-Romagna, Italy

Fondazione Policlinico Universitario A Gemelli

Rome, Lazio, Italy

ASST di Pavia - Fondazione Istituto Neurologico Mondino IRCCS

Pavia, Lombardy, Italy

Azienda Ospedaliero Universitaria A Meyer - INCIPIT - PIN

Florence, Tuscany, Italy

Aichi Medical University Hospital

Nagakute-Shi, Aiti, Japan

Fukuoka Children's Hospital

Fukuoka, Hukuoka, Japan

Kumamoto-Ezuko Medical Center for The Severely Disabled

Kumamoto, Kumamoto, Japan

National Hospital Organization Nagasaki Medical Center

Omura-Shi, Nagasaki, Japan

National Hospital Organization Nishi-Niigata Chuo National Hospital

Niigata, Niigata, Japan

Okayama University Hospital

Okayama, Okayama-ken, Japan

Yasuhara Childrens Clinic

Neyagawa, Osaka, Japan

Osaka City General Hospital

Osaka, Osaka, Japan

Osaka University Hospital

Suita-Shi, Osaka, Japan

National Hospital Organization Shizuoka Institute of Epilepsy and Neurological Disorders

Shizuoka, Shizuoka, Japan

National Center of Neurology and Psychiatry

Kodaira-Shi, Tokyo, Japan

Childrens University Hospital

Riga, Latvia

Kempenhaeghe - PPDS

Heeze, North Brabant, Netherlands

Stichting Epilepsie Instellingen Nederland

Zwolle, Overijssel, Netherlands

Centrum Medyczne Plejady

Krakow, Lesser Poland Voivodeship, Poland

Uniwersyteckie Centrum Kliniczne

Gdansk, Poland

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

Poznan, Poland

UGMK-Zdorojie, LLC

Yekaterinburg, Russia

Clinic for Neurology and Psychiatry for Children and Youth

Belgrade, Serbia

Mother and Child Health Care Institute of Serbia Dr Vukan Cupic

Belgrade, Serbia

University Clinical Center Nis

Niš, Serbia

Children and Youth Health Care Institute of Vojvodina

Novi Sad, Serbia

Clinica Universidad Navarra

Pamplona, Navarre, Spain

Hospital Universitario Vall d'Hebron - PPDS

Barcelona, Spain

Hospital Regional Universitario de Malaga Hospital General

Málaga, Spain

Centro de Neurologia Avanzada

Seville, Spain

Hospital Universitari i Politecnic La Fe de Valencia

Valencia, Spain

Municipal Institution Dnipropetrovsk Regional Children Clinical Hospital of DRC

Dnipro, Dnipropetrovsk Oblast, Ukraine

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

Dnipro, Dnipropetrovsk Oblast, Ukraine

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

Ivano-Frankivsk, Ukraine

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

Kyiv, Ukraine

SI Ukr. Med. Rehabilitation Center For Children With Organic Injury of Nervous System of MoH of Ukr

Kyiv, Ukraine

Clinical Research Directory

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

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (98)