Last updated on November 2019

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

Brief description of study

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.

Detailed Study Description

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.

Clinical Study Identifier: NCT03650452

Find a site near you

Start Over

Austin Hospital

Heidelberg West, Australia
  Connect »