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

Activo, no reclutaFase 3ClinicalTrials.gov

ID: NCT05206513RENIS: IS004847Tipo: INTERVENTIONALInicio: 15 de abr de 2022Fin estimado: 1 de jun de 2026

Neurología Gastroenterología Dermatología

Traducción no disponible, mostrando original

Resumen

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.

Elegibilidad

Edad mínima: 6 YearsEdad máxima: 70 YearsSexo: ALL

Criterios de inclusión

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.

Criterios de exclusión

Are pregnant or breastfeeding.
Participants will be excluded from the study if they meet any of the following criteria:
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.

Intervenciones

drug

Placebo

Capsule, administered once daily orally or via gastrostomy/gastrojejunostomy tube

drug

Valbenazine

Capsule, administered once daily orally or via gastrostomy/gastrojejunostomy tube

Ubicaciones

Neurocrine Clinical Site

Buenos Aires, Argentina

Neurocrine Clinical Site

Buenos Aires, Argentina

Patrocinadores

PrincipalNeurocrine Biosciences

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