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A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy, Safety, and Tolerability of TAK-935 (OV935) as an Adjunctive Therapy in Pediatric Participants With Developmental and/or Epileptic Encephalopathies
Sponsor: Takeda
Summary
The purpose of this study is to investigate the effect on the frequency of all seizures (convulsive and drop) in participants treated with TAK-935 compared to placebo.
Official title: A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Tolerability of TAK-935 (OV935) as an Adjunctive Therapy in Pediatric Patients With Developmental and/or Epileptic Encephalopathies
Key Details
Gender
All
Age Range
2 Years - 17 Years
Study Type
INTERVENTIONAL
Enrollment
141
Start Date
2018-08-08
Completion Date
2020-07-20
Last Updated
2026-09-14
Healthy Volunteers
No
Interventions
TAK-935
TAK-935 tablets or mini-tablets.
Placebo
TAK-935 placebo-matching tablets or mini-tablets.
Locations (44)
Phoenix Children's Hospital
Phoenix, Arizona, United States
Children's Hospital Los Angeles
Los Angeles, California, United States
Colorado Children's Hospital
Aurora, Colorado, United States
Nicklaus Children's Hospital
Miami, Florida, United States
Pediatric Neurology PA
Orlando, Florida, 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
Mayo Clinic - PPDS
Rochester, Minnesota, 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
Columbia University Medical Center
New York, New York, United States
Wake Forest Baptist Medical Center
Winston-Salem, North Carolina, United States
Medical University of South Carolina
Charleston, South Carolina, United States
Cook Children's Medical Center
Fort Worth, Texas, United States
Monash Children's Hospital
Clayton, Victoria, Australia
Austin Hospital
Heidelberg West, Victoria, Australia
Hospital For Sick Children
Toronto, Ontario, Canada
Peking University First Hospital
Beijing, China
Capital Medical University (CMU) - Beijing Children's Hospital
Beijing, China
Beijing Children's Hospital,Capital Medical University
Beijing, China
Xiangya Hospital Central South University
Changsha, China
Children's Hospital of Fudan University
Shanghai, China
Shenzhen Children's Hospital
Shenzhen, China
Sheba Medical Center-PPDS
Tel Litwinsky, Ramat Gan, Israel
Soroka University Medical Centre
Bear Sheva, Israel
Bnai Zion Medical Center
Haifa, Israel
Edith Wolfson Medical Center
Holon, Israel
Hadassah Medical Center
Jerusalem, Israel
Schneider Childrens Medical Center of Israel
Petah Tikva, Israel
Tel Aviv Sourasky Medical Center
Tel Aviv, Israel
Szpital Kliniczny im. H.Swiecickiego Uniwersytetu Medycznego im. Karola Marcinkowskiego w Poznaniu
Poznan, Greater Poland Voivodeship, Poland
Uniwersyteckie Centrum Kliniczne - PPDS
Gdansk, Pomeranian Voivodeship, Poland
Centrum Medyczne Plejady
Krakow, Poland
Samodzielny Publiczny Dzieciecy Szpital Kliniczny w Warszawie
Warsaw, Poland
Instytut Pomnik Centrum Zdrowia Dziecka
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
Largo da Maternidade de Julio DinisCentro Materno Infantil do Norte
Porto, Portugal
Clinica Universidad Navarra
Pamplona, Navarre, Spain
Hospital Vithas La Salud
Granada, Spain
Hospital Ruber Internacional
Madrid, Spain
Hospital Universitari i Politecnic La Fe de Valencia
Valencia, Spain