A Phase 3 interventional study of Placebo and Valbenazine in Dyskinesia and Cerebral Palsy, sponsored by Neurocrine Biosciences. Completed at 38 sites in 10 countries. Open to participants aged 6 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-04-29.
Sponsored by Neurocrine Biosciences · Phase 3, Interventional, and Treatment
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.
179 studies on the registry are indexed under Dyskinesias; 24 are open to participants now.
This study's enrollment of 86 is above the median of 36 across 139 interventional studies indexed under Dyskinesias.
Browse Dyskinesias studies →Neurocrine Biosciences is the lead sponsor of 86 studies on the registry; 16 are open to participants now.
Of its 35 completed or terminated interventional studies of FDA-regulated products, 23 (66%) have results posted.
Counted across the registry records on this site, refreshed daily.
Key Inclusion Criteria:
Key Exclusion Criteria:
Participants will be excluded from the study if they meet any of the following criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
QT and QTc
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECG (electrocardiogram)
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Placebo dosed for 14 weeks (double-blind treatment period) followed by open-label valbenazine treatment. Participants may opt to enter an open-label valbenazine treatment extension phase.
Drug: Placebo · Drug: Valbenazine
Valbenazine dosed for 14 weeks (double-blind treatment period) followed by open-label valbenazine treatment. Participants may opt to enter an open-label valbenazine treatment extension phase.
Drug: Valbenazine
Capsule, administered once daily orally or via gastrostomy/gastrojejunostomy tube
Capsule, administered once daily orally or via gastrostomy/gastrojejunostomy tube
Also known as: NBI-98854
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
Time frame: Baseline, Week 12 and Week 14
Change in the Clinical Global Impression of Severity (CGI-S) Score from Baseline to Week 14
Time frame: Baseline, Week 14
Change in the Movement Disorders - Childhood Rating Scale (MD-CRS) Part I Score from Baseline to the Average of the Week 12 and Week 14 Assessments
Time frame: Baseline, Week 12 and Week 14
Change in the Total Maximal Dystonia (TMD) Score of the UHDRS from Baseline to the Average of the Week 12 and Week 14 Assessments
Time frame: Baseline, Week 12 and Week 14
Patient Global Impression of Improvement (PGI-I) Score at Week 14
Time frame: Week 14
Caregiver Global Impression of Improvement (CaGI-I) Score at Week 14
Time frame: Week 14
Clinical Global Impression of Improvement (CGI-I) Score at Week 14
Time frame: Week 14
Goal Attainment Score at Week 14 Using the Goal Attainment Scale (GAS)
Time frame: Week 14
Change in Pain Assessment from Baseline to Week 14 Using the Faces Pain Scale-Revised (FPS-R)
Time frame: Baseline, Week 14
Change in the UHDRS Total Motor Score (TMS) from Baseline to the Average of the Week 12 and Week 14 Assessments
Time frame: Baseline, Week 12 and Week 14
Plan to share: No
No publications or documents are linked to this record.
Ran from Apr 2022 to primary completion in Oct 2025, 42 months.
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This study is completed, as verified in Feb 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Valbenazine