CompletedPhase 2

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

United States141 participantsStarted 2018-08-08

Plain-language 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.

Who can participate

Age range2 Years – 17 Years

SexALL

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Inclusion criteria

✓. 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

Exclusion criteria

✕. 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

What they're measuring

Percent Change From Baseline in Seizure Frequency Per 28 Days During the Maintenance Period

Timeframe: Baseline; Maintenance Period: Weeks 9 to 20

Trial details

NCT IDNCT03650452

SponsorTakeda

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2020-06-09

Results submitted2021-01-19

View on ClinicalTrials.gov More Epilepsy trials