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Completed Phase 2 Interventional Results available

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

ClinicalTrials.gov ID: NCT03650452

Public ClinicalTrials.gov record NCT03650452. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Oct 21, 2026, 5:15 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

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 summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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 identification

NCT ID
NCT03650452
Recruitment status
Completed
Study type
Interventional
Phase
Phase 2
Lead sponsor
Takeda
Industry
Enrollment
141 participants

Conditions and interventions

Eligibility (public fields only)

Age range
2 Years to 17 Years
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Aug 8, 2018 (Actual)
Primary completion
Jun 9, 2020 (Actual)
Completion
Jul 20, 2020 (Actual)
Last update posted
Sep 14, 2026

2018 – 2020

United States locations

U.S. sites
15
U.S. states
12
U.S. cities
15
Facility City State ZIP Site status
Phoenix Children's Hospital Phoenix Arizona 85016 —
Children's Hospital Los Angeles Los Angeles California 90027 —
Colorado Children's Hospital Aurora Colorado 80045 —
Nicklaus Children's Hospital Miami Florida 33155 —
Pediatric Neurology PA Orlando Florida 32819 —
Rare Disease Research, LLC Atlanta Georgia 30318 —
Center for Rare Neurological Diseases Norcross Georgia 30093 —
Ann and Robert H Lurie Childrens Hospital of Chicago Chicago Illinois 60611 —
Mayo Clinic - PPDS Rochester Minnesota 55905 —
Northeast Regional Epilepsy Group Hackensack New Jersey 07601 —
Children's Hospital at Saint Peter's University Hospital New Brunswick New Jersey 08901 —
Columbia University Medical Center New York New York 10032 —
Wake Forest Baptist Medical Center Winston-Salem North Carolina 27157 —
Medical University of South Carolina Charleston South Carolina 29425 —
Cook Children's Medical Center Fort Worth Texas 76104 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 29 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT03650452, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Sep 14, 2026 · Synced Oct 21, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT03650452 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →