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A Study of Soticlestat in Adults and Children With Rare Epilepsies
Sponsor: Takeda
Summary
The main aim is to assess the long-term safety and tolerability of soticlestat when used along with other anti-seizure treatment. Participants will receive soticlestat twice a day. Participants will visit the study clinic every 2-6 months throughout the study. Study treatments may continue as long as the participant is receiving benefit from it.
Official title: A Phase 2, Prospective, Interventional, Open-Label, Multi-Site, Extension Study to Assess the Long-Term Safety and Tolerability of Soticlestat (TAK-935) as Adjunctive Therapy in Subjects With Developmental Epileptic Encephalopathies Including Dravet Syndrome, Lennox Gastaut Syndrome, CDKL5 Deficiency Disorder, and Chromosome 15 Duplication Syndrome (ENDYMION 1)
Key Details
Gender
All
Age Range
2 Years - Any
Study Type
INTERVENTIONAL
Enrollment
156
Start Date
2018-07-19
Completion Date
2025-07-30
Last Updated
2026-09-04
Healthy Volunteers
No
Interventions
Soticlestat
Soticlestat tablets or mini-tablets.
Locations (59)
Xenosciences Inc
Phoenix, Arizona, United States
David Geffen School of Medicine at UCLA
Los Angeles, California, United States
David Geffen School of Medicine at UCLA
Los Angeles, California, United States
Colorado Children's Hospital
Aurora, Colorado, United States
Colorado Children's Hospital
Aurora, Colorado, United States
Nicklaus Children's Hospital
Miami, Florida, United States
Nicklaus Children's Hospital
Miami, Florida, United States
Medsol Clinical Research Center Inc
Port Charlotte, Florida, United States
Medsol Clinical Research Center Inc
Port Charlotte, Florida, United States
University of South Florida
Tampa, Florida, United States
Pediatric Neurology PA
Winter Park, Florida, United States
Rare Disease Research, LLC
Atlanta, Georgia, United States
Rare Disease Research, LLC
Atlanta, Georgia, United States
Center for Rare Neurological Diseases
Norcross, Georgia, United States
Ann and Robert H Lurie Childrens Hospital of Chicago
Chicago, Illinois, United States
Bluegrass Epilepsy Research LLC
Lexington, Kentucky, United States
Boston Children's Hospital
Boston, Massachusetts, United States
Mayo Clinic - PIN
Rochester, Minnesota, United States
Minnesota Epilepsy Group PA
Saint Paul, Minnesota, United States
Max Benzaquen, M.D., PC
Chesterfield, Missouri, United States
Northeast Regional Epilepsy Group
Hackensack, New Jersey, United States
Children's Hospital at Saint Peter's University Hospital
New Brunswick, New Jersey, United States
NYU - Ambulatory Care Center (ACC)
New York, New York, United States
Columbia University Medical Center - PIN
New York, New York, United States
Wake Forest Baptist Medical Center - PPDS
Winston-Salem, North Carolina, United States
Medical University of South Carolina Childrens Hospital - PIN
Charleston, South Carolina, United States
Cook Children's Medical Center - Jane and John Justin Neurosciences Center
Fort Worth, Texas, United States
Monash Children's Hospital
Clayton, Victoria, Australia
Austin Hospital
Heidelberg, Victoria, Australia
Austin Hospital
Heidelberg West, Victoria, Australia
Hospital For Sick Children
Toronto, Ontario, Canada
Shenzhen Children's Hospital
Shenzhen, Guangdong, China
Children's Hospital of Fudan University
Shanghai, Shanghai Municipality, China
Peking University First Hospital
Beijing, China
Beijing Children's Hospital,Capital Medical University
Beijing, China
Beijing Children's Hospital,Capital Medical University
Beijing, China
Xiangya Hospital Central South University
Changsha, China
Xiangya Hospital of Central South University
Changsha, China
Tel Aviv Sourasky Medical Center PPDS
Tel Aviv, Tel Aviv, Israel
Soroka University Medical Centre
Beersheba, Israel
Bnai Zion Medical Center
Haifa, Israel
Edith Wolfson Medical Center
Holon, Israel
Schneider Children's Medical Center of Israel - Petah Tikvah - PIN
Petah Tikva, Israel
Sheba Medical Center - PPDS
Ramat Gan, Israel
Sheba Medical Center - PPDS
Ramat Gan, Israel
Tel Aviv Sourasky Medical Center PPDS
Tel Aviv, Israel
Szpital Kliniczny im. H.Swiecickiego Uniwersytetu Medycznego im. Karola Marcinkowskiego w Poznaniu
Poznan, Greater Poland Voivodeship, Poland
Uniwersyteckie Centrum Kliniczne
Gdansk, Pomeranian Voivodeship, Poland
Centrum Medyczne Plejady
Krakow, Poland
Samodzielny Publiczny Dzieciecy Szpital Kliniczny w Warszawie
Warsaw, Poland
NZOZ Centrum Neurologii Dzieciecej i Leczenia Padaczki
Kielce, Świętokrzyskie Voivodeship, Poland
Centro Hospitalar Lisboa Central- Hospital Dona Estefania
Lisbon, Portugal
Centro Hospitalar Lisboa Norte, E.P.E. Hospital de Santa Maria
Lisbon, Portugal
Centro Hospitalar Lisboa Norte, E.P.E. Hospital de Santa Maria
Lisbon, Portugal
Hospital Ruber Internacional (Grupo Quironsalud)
Madrid, Madrid, Communidad Delaware, Spain
Clinica Universidad Navarra
Pamplona, Navarre, Spain
Hospital Vithas La Salud
Granada, Spain
Hospital Ruber Internacional (Grupo Quironsalud)
Madrid, Spain
Hospital Universitari i Politecnic La Fe de Valencia
Valencia, Spain