At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 141 enrolled
Drug / intervention
TAK-935 +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 2 clinical trial evaluating TAK-935 and Placebo for Epilepsy and 2 related conditions. Completed, enrolled 141 participants across 44 sites in 8 countries.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsEpilepsy, Dravet Syndrome, Lennox-Gastaut Syndrome
CountriesAustralia, Canada, China, Israel, Poland, Portugal, Spain, United States
CollaboratorsHealx AI
Timeline
Phase 2CompletedFinished
20192020202120222023202420252026
Enrollment StartAug 2018
First PostedAug 2018
Primary CompletionJun 2020
Study CompletionJul 2020
TodayJul 2026
First PostedAug 28, 2018
Enrollment StartAug 8, 2018
Primary CompletionJun 9, 2020
Study CompletionJul 20, 2020
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 7.8 years ago
Interventions
TAK-935drug
TAK-935 tablets or mini-tablets.
Placebodrug
TAK-935 placebo-matching tablets or mini-tablets.