TRIAL TITLE: A Study of TEV-50717 (Deutetrabenazine) for the Treatment of Dyskinesia in Cerebral Palsy in Children and Adolescents (RECLAIM-DCP)

DESCRIPTION: "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."

SPONSOR: Teva Branded Pharmaceutical Products R&D, Inc.

INDICATION: Cerebral Palsy, Dyskinetic

STUDY PROTOCOL: TV50717-CNS-30080

PHASE: 3

STATUS: Past

RECRUITING PATIENTS: No

TRIAL TITLE: A Study to Test if TEV-50717 is Safe and Effective in Relieving Abnormal Involuntary Movements in Cerebral Palsy

DESCRIPTION: "Study TV50717-CNS-30081 is a 55-week study in which patients who have successfully completed the parent study (Study TV50717-CNS-30080) may be eligible to enroll in this study.

The primary objective of this study is to evaluate the safety and tolerability of long-term therapy with TEV-50717 in children and adolescents with DCP.

The secondary objective of this study is to evaluate the efficacy of long-term therapy with TEV-50717 in reducing the severity of DCP."

SPONSOR: Teva Branded Pharmaceutical Products R&D, Inc.

INDICATION: Cerebral Palsy, Dyskinetic

STUDY PROTOCOL: TV50717-CNS-30081

PHASE: 3

STATUS: Past

RECRUITING PATIENTS: No