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COMPLETED
NCT03650452
PHASE2

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

View on ClinicalTrials.gov

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

DRUG

TAK-935

TAK-935 tablets or mini-tablets.

DRUG

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