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

Completed · Phase 2 · Has a placebo group

Conditions studied: Epilepsy, Dravet Syndrome, Lennox-Gastaut Syndrome

In brief

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.

Key facts

Study ID

NCT03650452

Run by

Takeda

People needed

141

Starts

2018-08-08

Expected to finish

2020-07-20

Last updated by the study team

2021-02-18

Who can join

Age: 2 and older, up to 17. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

• 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
• Non-epileptic events that cannot be reliably distinguished from epileptic seizures
• Participation in a clinical study involving another study drug in the previous month

Where it is running

• 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

Full record on ClinicalTrials.gov

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