A Study of TEV-50717 (Deutetrabenazine) for the Treatment of Dyskinesia in Cerebral Palsy in Children and Adolescents
Status:
Recruiting
Trial end date:
2023-06-28
Target enrollment:
Participant gender:
Summary
CP (cerebral palsy) refers to a group of neurological disorders that appear in infancy or
early childhood and permanently affect body movement and muscle coordination. CP is caused by
damage to or abnormalities inside the developing brain that disrupt the brain's ability to
control movement and maintain posture and balance. The signs of CP usually appear in the
early months of life, although specific diagnosis may be delayed until the age of 2 years or
older. 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 parallel 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.
Phase:
Phase 3
Details
Lead Sponsor:
Teva Branded Pharmaceutical Products R&D, Inc. Teva Branded Pharmaceutical Products, R&D Inc.