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COMPLETED
NCT03166215
PHASE1/PHASE2

Study of TAK-935 as an Adjunctive Therapy in Participants With Developmental and/or Epileptic Encephalopathies

Sponsor: Takeda

View on ClinicalTrials.gov

Summary

The purpose of this study is to characterize the multiple-dose safety and tolerability profile of TAK-935 in adult participants with developmental and/or epileptic encephalopathies.

Official title: A Phase 1b/2a Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Dose-Escalation Study With an Open-Label Part to Examine the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of TAK-935 as an Adjunctive Therapy in Subjects With Developmental and/or Epileptic Encephalopathies

Key Details

Gender

All

Age Range

18 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

18

Start Date

2017-08-17

Completion Date

2018-09-19

Last Updated

2026-09-14

Healthy Volunteers

No

Interventions

DRUG

TAK-935

TAK-935 tablets.

DRUG

Placebo

TAK-935 placebo-matching tablets.

Locations (11)

Xenoscience

Phoenix, Arizona, United States

Medsol Clinical Research Center

Port Charlotte, Florida, United States

University of South Florida

Tampa, Florida, United States

Center for Integrative Rare Disease Research

Atlanta, Georgia, United States

Bluegrass Epilepsy Research

Lexington, Kentucky, United States

Mid-Atlantic Epilepsy and Sleep Center

Bethesda, Maryland, United States

The Comprehensive Epilepsy Care Center for Children and Adults

St Louis, Missouri, United States

Northeast Regional Epilepsy Group

Hackensack, New Jersey, United States

Thomas Jefferson University

Philadelphia, Pennsylvania, United States

Medical University of South Carolina

Charleston, South Carolina, United States

University of Virginia Health Sciences Center

Charlottesville, Virginia, United States