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

Study Purpose

The purpose of this study is to investigate the effect on the frequency of all seizures (convulsive and drop) in patients treated with TAK-935 compared to placebo.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 2 Years - 17 Years
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

1. Male and female patients aged greater than or equal to (>=) 2 and less than or equal to (<=) 17 years 2. Clinical diagnosis of Dravet Syndrome or LGS 3. Weight of >=10 kilogram (kg) at the Screening visit 4. Currently taking 1 to 4 anti-epileptic drugs (AED) at a stable dose 5. Failed to become and remain seizure free with trials of at least 2 AEDs

Exclusion Criteria:

1. Has been admitted to a medical facility and intubated for treatment of status epilepticus 2 or more times in the 3 months immediately prior to the screening visit 2. Non-epileptic events that cannot be reliably distinguished from epileptic seizures 3. Participation in a clinical study involving another study drug in the previous month

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT03650452
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 2
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Takeda
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

N/A
Principal Investigator Affiliation N/A
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

IndustryIndustry
Overall Status Recruiting
Countries Australia, Canada, China, Israel, Poland, Portugal, Spain, United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Epilepsy, Dravet Syndrome, Lennox-Gastaut Syndrome
Additional Details

The drug being tested in this study is called TAK-935 (OV935). This randomized, double-blind study will assess the effects of TAK-935 (OV935), compared to placebo, on efficacy, safety, and tolerability in pediatric patients with Dravet syndrome or LGS. This multi-center trial will be conducted worldwide and will enroll approximately 126 patients. Patients will be randomized based on their diagnosis in 2 categories; Dravet syndrome and LGS. The study will consist of 2 periods: Screening Period and Treatment Period. The overall duration of Treatment Period is 20 weeks including 8-week Dose Optimization Period and 12-week Maintenance Period. The overall time to patients in this study is approximately 30 weeks. Patients completing this study will have an option to enroll in the open-label extension study, under a separate protocol.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Cook Children's Medical Center, Fort Worth, Texas

Status

Recruiting

Address

Cook Children's Medical Center

Fort Worth, Texas, 76104

Medical University of South Carolina, Charleston, South Carolina

Status

Recruiting

Address

Medical University of South Carolina

Charleston, South Carolina, 29425

Wake Forest Baptist Medical Center, Winston-Salem, North Carolina

Status

Recruiting

Address

Wake Forest Baptist Medical Center

Winston-Salem, North Carolina, 27157

Columbia University Medical Center, New York, New York

Status

Recruiting

Address

Columbia University Medical Center

New York, New York, 10032

New Brunswick, New Jersey

Status

Recruiting

Address

Children's Hospital at Saint Peter's University Hospital

New Brunswick, New Jersey, 08901

Northeast Regional Epilepsy Group, Hackensack, New Jersey

Status

Recruiting

Address

Northeast Regional Epilepsy Group

Hackensack, New Jersey, 07601

Mayo Clinic - PPDS, Rochester, Minnesota

Status

Recruiting

Address

Mayo Clinic - PPDS

Rochester, Minnesota, 55905

Chicago, Illinois

Status

Recruiting

Address

Ann and Robert H Lurie Childrens Hospital of Chicago

Chicago, Illinois, 60611

Center for Rare Neurological Diseases, Norcross, Georgia

Status

Recruiting

Address

Center for Rare Neurological Diseases

Norcross, Georgia, 30093

Rare Disease Research, LLC, Atlanta, Georgia

Status

Recruiting

Address

Rare Disease Research, LLC

Atlanta, Georgia, 30318

Pediatric Neurology PA, Orlando, Florida

Status

Recruiting

Address

Pediatric Neurology PA

Orlando, Florida, 32819

Nicklaus Children's Hospital, Miami, Florida

Status

Recruiting

Address

Nicklaus Children's Hospital

Miami, Florida, 33155

Colorado Children's Hospital, Aurora, Colorado

Status

Recruiting

Address

Colorado Children's Hospital

Aurora, Colorado, 80045

Children's Hospital Los Angeles, Los Angeles, California

Status

Recruiting

Address

Children's Hospital Los Angeles

Los Angeles, California, 90027

Phoenix Children's Hospital, Phoenix, Arizona

Status

Recruiting

Address

Phoenix Children's Hospital

Phoenix, Arizona, 85016

International Sites

Valencia, Spain

Status

Recruiting

Address

Hospital Universitari i Politecnic La Fe de Valencia

Valencia, , 46026

Hospital Ruber Internacional, Madrid, Spain

Status

Recruiting

Address

Hospital Ruber Internacional

Madrid, , 28034

Hospital Vithas La Salud, Granada, Spain

Status

Recruiting

Address

Hospital Vithas La Salud

Granada, , 18008

Clinica Universidad Navarra, Pamplona, Navarre, Spain

Status

Recruiting

Address

Clinica Universidad Navarra

Pamplona, Navarre, 31008

Porto, Portugal

Status

Recruiting

Address

Largo da Maternidade de Julio DinisCentro Materno Infantil do Norte

Porto, , 4050-651

Lisboa, Portugal

Status

Recruiting

Address

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

Lisboa, , 1649-035

Lisboa, Portugal

Status

Recruiting

Address

Centro Hospitalar Lisboa Central- Hospital Dona Estefania

Lisboa, , 1169-045

Instytut Pomnik Centrum Zdrowia Dziecka, Warsaw, Poland

Status

Recruiting

Address

Instytut Pomnik Centrum Zdrowia Dziecka

Warsaw, , 04-730

Warsaw, Poland

Status

Recruiting

Address

Samodzielny Publiczny Dzieciecy Szpital Kliniczny w Warszawie

Warsaw, , 02-091

Centrum Medyczne Plejady, Krakow, Poland

Status

Recruiting

Address

Centrum Medyczne Plejady

Krakow, , 30-363

Poznan, Wielkopolskie, Poland

Status

Recruiting

Address

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

Poznan, Wielkopolskie, 60-355

Kielce, Swietokrzyskie, Poland

Status

Recruiting

Address

NZOZ Centrum Neurologii Dzieciecej i Leczenia Padaczki

Kielce, Swietokrzyskie, 25-316

Uniwersyteckie Centrum Kliniczne - PPDS, Gdansk, Pomorskie, Poland

Status

Recruiting

Address

Uniwersyteckie Centrum Kliniczne - PPDS

Gdansk, Pomorskie, 80-211

Chaim Sheba Medical Center, Tel Hashomer, Israel

Status

Recruiting

Address

Chaim Sheba Medical Center

Tel Hashomer, , 52621

Tel Aviv Sourasky Medical Center, Tel Aviv, Israel

Status

Recruiting

Address

Tel Aviv Sourasky Medical Center

Tel Aviv, , 64239

Petach Tikva, Israel

Status

Recruiting

Address

Schneider Childrens Medical Center of Israel

Petach Tikva, , 49202

Hadassah Medical Center, Jerusalem, Israel

Status

Recruiting

Address

Hadassah Medical Center

Jerusalem, , 91120

Edith Wolfson Medical Center, Holon, Israel

Status

Recruiting

Address

Edith Wolfson Medical Center

Holon, , 58100

Bnai Zion Medical Center, Haifa, Israel

Status

Recruiting

Address

Bnai Zion Medical Center

Haifa, , 31408

Bnai Zion Medical Center, Haifa, Israel

Status

Recruiting

Address

Bnai Zion Medical Center

Haifa, , 31048

Soroka University Medical Centre, Bear Sheva, Israel

Status

Recruiting

Address

Soroka University Medical Centre

Bear Sheva, , 84101

Sheba Medical Center-PPDS, Tel Hashomer,, Ramat Gan, Israel

Status

Recruiting

Address

Sheba Medical Center-PPDS

Tel Hashomer,, Ramat Gan, 52621

Shenzhen Children's Hospital, Shenzhen, China

Status

Recruiting

Address

Shenzhen Children's Hospital

Shenzhen, , 518026

Children's Hospital of Fudan University, Shanghai, China

Status

Recruiting

Address

Children's Hospital of Fudan University

Shanghai, , 201102

Changsha, China

Status

Recruiting

Address

Xiangya Hospital Central South University

Changsha, , 410078

Beijing, China

Status

Recruiting

Address

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

Beijing, , 100045

Peking University First Hospital, Beijing, China

Status

Recruiting

Address

Peking University First Hospital

Beijing, , 100034

Hospital For Sick Children, Toronto, Ontario, Canada

Status

Recruiting

Address

Hospital For Sick Children

Toronto, Ontario, M5G 1X8

Austin Hospital, Heidelberg West, Victoria, Australia

Status

Recruiting

Address

Austin Hospital

Heidelberg West, Victoria, 3081

The content provided on clinical trials is for informational purposes only and is not a substitute for medical consultation with your healthcare provider. We do not recommend or endorse any specific study and you are advised to discuss the information shown with your healthcare provider. While we believe the information presented on this website to be accurate at the time of writing, we do not guarantee that its contents are correct, complete, or applicable to any particular individual situation. We strongly encourage individuals to seek out appropriate medical advice and treatment from their physicians. We cannot guarantee the availability of any clinical trial listed and will not be responsible if you are considered ineligible to participate in a given clinical trial. We are also not liable for any injury arising as a result of participation.