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

PHASE2CompletedINTERVENTIONAL
Enrollment

141

Participants

Timeline

Start Date

August 8, 2018

Primary Completion Date

June 9, 2020

Study Completion Date

July 20, 2020

Conditions
EpilepsyDravet SyndromeLennox-Gastaut Syndrome
Interventions
DRUG

TAK-935

TAK-935 tablets or mini-tablets.

DRUG

Placebo

TAK-935 placebo-matching tablets or mini-tablets.

Trial Locations (44)

3081

Austin Hospital, Heidelberg West

3168

Monash Children's Hospital, Clayton

10032

Columbia University Medical Center, New York

18008

Hospital Vithas La Salud, Granada

27157

Wake Forest Baptist Medical Center, Winston-Salem

28034

Hospital Ruber Internacional, Madrid

29425

Medical University of South Carolina, Charleston

30093

Center for Rare Neurological Diseases, Norcross

30318

Rare Disease Research, LLC, Atlanta

31008

Clinica Universidad Navarra, Pamplona

31048

Bnai Zion Medical Center, Haifa

32819

Pediatric Neurology PA, Orlando

33155

Nicklaus Children's Hospital, Miami

46026

Hospital Universitari i Politecnic La Fe de Valencia, Valencia

49202

Schneider Childrens Medical Center of Israel, Petah Tikva

52621

Sheba Medical Center-PPDS, Tel Litwinsky

55905

Mayo Clinic - PPDS, Rochester

58100

Edith Wolfson Medical Center, Holon

60611

Ann and Robert H Lurie Childrens Hospital of Chicago, Chicago

64239

Tel Aviv Sourasky Medical Center, Tel Aviv

76104

Cook Children's Medical Center, Fort Worth

80045

Colorado Children's Hospital, Aurora

84101

Soroka University Medical Centre, Bear Sheva

85016

Phoenix Children's Hospital, Phoenix

90027

Children's Hospital Los Angeles, Los Angeles

91120

Hadassah Medical Center, Jerusalem

100034

Peking University First Hospital, Beijing

100045

Capital Medical University (CMU) - Beijing Children's Hospital, Beijing

100069

Beijing Children's Hospital,Capital Medical University, Beijing

201102

Children's Hospital of Fudan University, Shanghai

410078

Xiangya Hospital Central South University, Changsha

518026

Shenzhen Children's Hospital, Shenzhen

07601

Northeast Regional Epilepsy Group, Hackensack

08901

Children's Hospital at Saint Peter's University Hospital, New Brunswick

M5G 1X8

Hospital For Sick Children, Toronto

60-355

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

80-211

Uniwersyteckie Centrum Kliniczne - PPDS, Gdansk

30-363

Centrum Medyczne Plejady, Krakow

02-091

Samodzielny Publiczny Dzieciecy Szpital Kliniczny w Warszawie, Warsaw

04-730

Instytut Pomnik Centrum Zdrowia Dziecka, Warsaw

25-316

NZOZ Centrum Neurologii Dzieciecej i Leczenia Padaczki, Kielce

1169-045

Centro Hospitalar Lisboa Central- Hospital Dona Estefania, Lisbon

1649-035

Centro Hospitalar Lisboa Norte, E.P.E. Hospital de Santa Maria, Lisbon

4050-651

Largo da Maternidade de Julio DinisCentro Materno Infantil do Norte, Porto

Sponsors

Lead Sponsor

Collaborators (1)

All Listed Sponsors
collaborator

Healx AI

INDUSTRY

lead

Takeda

INDUSTRY

NCT03650452 - 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 | Biotech Hunter | Biotech Hunter