Study ID: TV50717-CNS-30080 | 2018-003742-17

Study Title

A Study of TEV-50717 (Deutetrabenazine) for the Treatment of Dyskinesia in Cerebral Palsy in Children and Adolescents

Teva Identifier

TV50717-CNS-30080 | 2018-003742-17

ClinicalTrials.gov Identifier

NCT03813238

Study Status

Recruiting

Trial Condition(s)

Cerebral Palsy, Dyskinetic

Interventions

Drug: Deutetrabenazine | Drug: Placebo

EudractCT Number

2018-003742-17

Study Description

TEV-50717 (deutetrabenazine, also known as SD-809) has already provided evidence for safe and effective use in 2 other hyperkinetic movement disorders, namely chorea in Huntington's disease (HD) and tardive dyskinesia (TD). Currently, there is no approved treatment available for Dyskinesia in cerebral palsy (DCP). The available treatment options address some of the manifestations of DCP. The study population will include pediatric and adolescent participants (6 through 18 years of age) with DCP with predominant choreiform movement disorder, who have had nonprogressive CP symptoms since infancy (≤2 years of age). Diagnosis of DCP is based on the Surveillance of Cerebral Palsy in Europe criteria.

This is a Phase 3 study that will evaluate the efficacy and safety of TEV-50717 administered as oral tablets at a starting dose of 6 mg once daily in participants (age 6 through 18 years, inclusive) with DCP with predominant choreiform movement disorder. The study will be conducted in multiple centers and will use 2 parFemale, Maleel treatment groups (ie, TEV-50717 and placebo) in which participants will be randomized in a 2:1 ratio.

"Predominant" in this instance indicates that the choreiform movement disorder is the main cause of impairment or distress.


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Key Participation Requirements

Gender

Female, Male

Age Range

6 Years to 18 Years

Trial Duration

August 6, 2019 - August 26, 2022

Phase

Phase 3

Study Type

Interventional


Location - Where to Participate

You may contact 1-888-483-8279 or email USMedInfo@tevapharm.com to obtain more information about study locations.

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