Trial · NCT04102579

Efficacy, Safety, and Tolerability of Valbenazine for the Treatment of Chorea Associated With Huntington Disease

NCT04102579, Phase 3, Completed, Neurocrine Biosciences; results first posted 2023-10-11

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Efficacy, Safety, and Tolerability of Valbenazine for the Treatment of Chorea Associated With Huntington Disease. Trials, record NCT04102579. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04102579

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Efficacy, Safety, and Tolerability of Valbenazine for the Treatment of Chorea Associated With Huntington Disease
NCT number: NCT04102579
Status: Completed
Phases: Phase 3
Enrollment: 128 participants, actual
Lead sponsor: Neurocrine Biosciences
Conditions: Chorea, Huntington
Interventions: Valbenazine, Placebo
First posted: 2019-09-25
Last updated: 2023-10-11
Results first posted: 2023-10-11

Source ClinicalTrials.gov

Registered outcomes5

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Change From Screening Period Baseline to Maintenance Period in the Unified Huntington's Disease Rating Scale (UHDRS) Total Maximal Chorea (TMC) Score.	Baseline (average of screening and Day -1), maintenance (average of Weeks 10 and 12)	The TMC is part of the motor assessment of the UHDRS and measures chorea in 7 different body parts including the face, oral-buccal-lingual region, trunk and each limb independently. The TMC score is the sum of the individual scores and ranges from 0 to 28. A decrease in TMC scores indicates improvement in chorea symptoms.
Secondary	Percent of Clinical Global Impression of Change (CGI-C) Responders at Week 12	Week 12	The CGI-C is a 7-point scale that rates the overall global change in chorea symptoms since the initiation of study drug dosing, ranging from 1 (very much improved) to 7 (very much worse), as assessed by the investigator or qualified clinician designee. Participants whose CGI-C score was either a 1 (very much improved) or a 2 (much improved) were classified as responders.
Secondary	Percent of Patient Global Impression of Change (PGI-C) Responders at Week 12	Week 12	The PGI-C is a 7-point scale that rates the overall global change in chorea symptoms since the initiation of study drug dosing, ranging from 1 (very much improved) to 7 (very much worse), as assessed by the participant. Participants whose PGI-C score was either a 1 (very much improved) or a 2 (much improved) were classified as responders.
Secondary	Change From Baseline to Week 12 in the Quality of Life in Neurological Disorders (Neuro-QoL) Upper Extremity Function T-Score	Baseline, Week 12	The Neuro-QoL Upper Extremity Function Short Form consists of 8 questions about physical abilities, rated from 1 (unable to do) to 5 (without any difficulty). The Neuro-QoL scores were standardized as T-scores with a mean of 50 and standard deviation of 10. Scores below 50 indicated below average upper extremity function. The change from baseline to Week 12 in the Neuro-QoL Upper Extremity Function T-score are presented here. An increase in score indicates increased function.
Secondary	Change From Baseline to Week 12 in the Neuro-QoL Lower Extremity Function T-Score	Baseline, Week 12	The Neuro-QoL Lower Extremity Function Short Form consists of 8 questions about physical abilities, rated from 1 (unable to do) to 5 (without any difficulty). The Neuro-QoL scores were standardized as T-scores with a mean of 50 and standard deviation of 10. Scores below 50 indicated below average upper extremity function. The change from baseline to Week 12 in the Neuro-QoL Upper Extremity Function T-score are presented here. An increase in score indicates better function.

Source ClinicalTrials.gov

Outcomes5

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Change From Screening Period Baseline to Maintenance Period in the Unified Huntington's Disease Rating Scale (UHDRS) Total Maximal Chorea (TMC) Score.	Baseline (average of screening and Day -1), maintenance (average of Weeks 10 and 12)	All participants who are randomly assigned to a treatment group and who had at least 1 evaluable TMC change from baseline score during the 12-week double-blind treatment period.	units on a scale	LEAST_SQUARES_MEAN
SECONDARY	Percent of Clinical Global Impression of Change (CGI-C) Responders at Week 12	Week 12	All participants who were randomly assigned to a treatment group, and who had at least 1 evaluable TMC change from baseline score and observed data at Week 12.	percentage of responders	NUMBER
SECONDARY	Percent of Patient Global Impression of Change (PGI-C) Responders at Week 12	Week 12	All participants who were randomly assigned to a treatment group, and who had at least 1 evaluable TMC change from baseline score and observed data at Week 12.	percentage of responders	NUMBER
SECONDARY	Change From Baseline to Week 12 in the Quality of Life in Neurological Disorders (Neuro-QoL) Upper Extremity Function T-Score	Baseline, Week 12	All participants who are randomly assigned to a treatment group and who had at least 1 evaluable TMC change from baseline score during the 12-week double-blind treatment period.	units on a scale	LEAST_SQUARES_MEAN
SECONDARY	Change From Baseline to Week 12 in the Neuro-QoL Lower Extremity Function T-Score	Baseline, Week 12	All participants who are randomly assigned to a treatment group and who had at least 1 evaluable TMC change from baseline score during the 12-week double-blind treatment period.	units on a scale	LEAST_SQUARES_MEAN

Source ClinicalTrials.gov

Results by group10

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Change From Screening Period Baseline to Maintenance Period in the Unified Huntington's Disease Rating Scale (UHDRS) Total Maximal Chorea (TMC) Score.	Valbenazine	-4.60	Standard Error 0.43	units on a scale
Change From Screening Period Baseline to Maintenance Period in the Unified Huntington's Disease Rating Scale (UHDRS) Total Maximal Chorea (TMC) Score.	Placebo	-1.44	Standard Error 0.44	units on a scale
Percent of Clinical Global Impression of Change (CGI-C) Responders at Week 12	Valbenazine	42.9		percentage of responders
Percent of Clinical Global Impression of Change (CGI-C) Responders at Week 12	Placebo	13.2		percentage of responders
Percent of Patient Global Impression of Change (PGI-C) Responders at Week 12	Valbenazine	52.7		percentage of responders
Percent of Patient Global Impression of Change (PGI-C) Responders at Week 12	Placebo	26.4		percentage of responders
Change From Baseline to Week 12 in the Quality of Life in Neurological Disorders (Neuro-QoL) Upper Extremity Function T-Score	Valbenazine	-1.58	Standard Error 1.01	units on a scale
Change From Baseline to Week 12 in the Quality of Life in Neurological Disorders (Neuro-QoL) Upper Extremity Function T-Score	Placebo	-3.00	Standard Error 1.04	units on a scale
Change From Baseline to Week 12 in the Neuro-QoL Lower Extremity Function T-Score	Valbenazine	-0.27	Standard Error 0.82	units on a scale
Change From Baseline to Week 12 in the Neuro-QoL Lower Extremity Function T-Score	Placebo	0.61	Standard Error 0.84	units on a scale

Source ClinicalTrials.gov

Participant flow8

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Valbenazine	64
Overall Study	STARTED	Placebo	64
Overall Study	Received at Least 1 Dose of Study Drug	Valbenazine	64
Overall Study	Received at Least 1 Dose of Study Drug	Placebo	63
Overall Study	COMPLETED	Valbenazine	57
Overall Study	COMPLETED	Placebo	54
Overall Study	NOT COMPLETED	Valbenazine	7
Overall Study	NOT COMPLETED	Placebo	10

Source ClinicalTrials.gov

Adverse events18

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	Fatigue	General disorders	Valbenazine	9	64
other	Fatigue	General disorders	Placebo	6	63
other	Fall	Injury, poisoning and procedural complications	Valbenazine	8	64
other	Fall	Injury, poisoning and procedural complications	Placebo	8	63
other	Somnolence	Nervous system disorders	Valbenazine	10	64
other	Somnolence	Nervous system disorders	Placebo	2	63
other	Akathisia	Nervous system disorders	Valbenazine	4	64
other	Akathisia	Nervous system disorders	Placebo	3	63
other	Rash	Skin and subcutaneous tissue disorders	Valbenazine	5	64
other	Rash	Skin and subcutaneous tissue disorders	Placebo	0	63

1 to 10 of 18Source ClinicalTrials.gov

See all 18 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Valbenazine	0	64
Total, all-cause mortality	Placebo	1	63
Total, other adverse events	Valbenazine	35	64
Total, other adverse events	Placebo	17	63
Total, serious adverse events	Valbenazine	1	64
Total, serious adverse events	Placebo	2	63

Source ClinicalTrials.gov

Papers2

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
32250312	DERIVED	PubMed
37210099	RESULT	PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons2

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
Valbenazine vs Placebo: deaths from any cause	Trial comparisons
Valbenazine vs Placebo: serious adverse events	Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

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