A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy, Safety, and Tolerability of Valbenazine for the Treatment of Dyskinesia Due to Cerebral Palsy

NBI-98854-DCP3018

The primary objective of this study is to evaluate the efficacy of valbenazine versus placebo on improving chorea in participants aged 6 to 70 years who have dyskinesia due to cerebral palsy (DCP) with choreiform movements.

2022-04-15

2025-06-01

2026-01-01

Recruiting

Early phase I

80

Key Inclusion Criteria: 1. Medically confirmed diagnosis of DCP (that is, a hyperkinetic movement disorder due to cerebral palsy \[CP\]) with choreiform movements. 2. Medical conditions are stable and expected to remain stable throughout the study. Key Exclusion Criteria: Participants will be excluded from the study if they meet any of the following criteria: 1. Are pregnant or breastfeeding. 2. Have a clinical diagnosis or history of dyskinesia due to condition other than CP. 3. Have inability to swallow soft solids, unless medications can be administered via a gastrostomy tube. 4. Have any suicidal behavior or suicidal ideation in the year prior to screening or on Day 1. 5. Is a substance abuser of any compound. 6. Known history of long QT syndrome or cardiac tachyarrhythmia, or clinically significant electrocardiogram (ECG) abnormalities.

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 80, 'type': 'ESTIMATED'}}

2024-03-12