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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 141 (actual)
• Sponsor: Takeda · Industry
• Sex: All
• Age: 2 Years – 17 Years
• Healthy volunteers: Not accepted

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.

Detailed 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 participants with Dravet syndrome (DS) or Lennox Gastaut syndrome (LGS). This multi-center trial will be conducted worldwide and will enroll approximately 126 participants. Participants will be randomized based on their diagnosis in 2 categories; DS or LGS. The study will consist of 2 periods: Screening Period and Treatment Period. The overall duration of Treatment Period is up to 20 weeks including 8-week Dose Optimization Period and 12-week Maintenance Period. The overall time to participants in this study is approximately 30 weeks. Participants completing this study will have an option to enroll in the open-label extension study, under a separate protocol.

Conditions

• Epilepsy
• Dravet Syndrome
• Lennox-Gastaut Syndrome

Interventions

Type	Name	Description
DRUG	TAK-935	TAK-935 tablets or mini-tablets.
DRUG	Placebo	TAK-935 placebo-matching tablets or mini-tablets.

Timeline

• Start date: 2018-08-08
• Primary completion: 2020-06-09
• Completion: 2020-07-20
• First posted: 2018-08-28
• Last updated: 2021-02-18
• Results posted: 2021-02-18

Locations

44 sites across 8 countries: United States, Australia, Canada, China, Israel, Poland, Portugal, Spain

Regulatory

• FDA-regulated drug study