CompletedPhase 3

Study to Assess the Efficacy, Safety, and Tolerability of Valbenazine for the Treatment of Dyskinesia Due to Cerebral Palsy

United States86 participantsStarted 2022-04-15

Plain-language summary

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

Who can participate

Age range6 Years – 70 Years

SexALL

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Inclusion criteria

✓. Medically confirmed diagnosis of DCP (that is, a hyperkinetic movement disorder due to cerebral palsy \[CP\]) with choreiform movements.
✓. Medical conditions are stable and expected to remain stable throughout the study.

Exclusion criteria

✕. Are pregnant or breastfeeding.
✕. Have a clinical diagnosis or history of dyskinesia due to condition other than CP.
✕. Have inability to swallow soft foods, unless medications can be administered via gastrostomy/gastrojejunostomy tube.
✕. Have any suicidal behavior or suicidal ideation in the year prior to screening or on Day 1.
✕. Is a substance abuser of any compound.
✕. Known history of long QT syndrome or cardiac tachyarrhythmia, or clinically significant electrocardiogram (ECG) abnormalities.

What they're measuring

Change in the Total Maximal Chorea (TMC) Score of the Unified Huntington Disease Rating Scale (UHDRS) from Baseline to the Average of the Week 12 and Week 14 assessments

Timeframe: Baseline, Week 12 and Week 14

Trial details

NCT IDNCT05206513

SponsorNeurocrine Biosciences

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-10-16

View on ClinicalTrials.gov More Dyskinesia trials