Phase 3
Completed N=128
Efficacy, Safety, and Tolerability of Valbenazine for the Treatment of Chorea Associated With Huntington Disease
Chorea, Huntington
Source: ClinicalTrials.gov NCT04102579 ↗
Enrolled (actual)
128
Serious AEs
2.4%
Results posted
Oct 2023
Primary outcomePrimary: Change From Screening Period Baseline to Maintenance Period in the Unified Huntington's Disease Rating Scale (UHDRS) Total Maximal Chorea (TMC) Score. — -4.60; -1.44 units on a scale — p=<0.0001
◆ Published Evidence
Established
69citations · ~23 / year
Safety and efficacy of valbenazine for the treatment of chorea associated with Huntington's disease (KINECT-HD): a phase 3, randomised, double-blind, placebo-controlled trial.
Summary
This is a Phase 3, randomized, double-blind, placebo-controlled study to evaluate the efficacy, safety, and tolerability of valbenazine to treat chorea in participants with Huntington disease.
Linked Publications (2)
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Safety and efficacy of valbenazine for the treatment of chorea associated with Huntington's disease (KINECT-HD): a phase 3, randomised, double-blind, placebo-controlled trial.
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Huntington's Disease Clinical Trials Corner: April 2020.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Screening Period Baseline to Maintenance Period in the Unified Huntington's Disease Rating Scale (UHDRS) Total Maximal Chorea (TMC) Score. |
-4.60; -1.44 | <0.0001 sig |
| SECONDARY Percent of Clinical Global Impression of Change (CGI-C) Responders at Week 12 |
42.9; 13.2 | 0.0007 sig |
| SECONDARY Percent of Patient Global Impression of Change (PGI-C) Responders at Week 12 |
52.7; 26.4 | 0.0062 sig |
| SECONDARY Change From Baseline to Week 12 in the Quality of Life in Neurological Disorders (Neuro-QoL) Upper Extremity Function T-Score |
-1.58; -3.00 | 0.3304 |
| SECONDARY Change From Baseline to Week 12 in the Neuro-QoL Lower Extremity Function T-Score |
-0.27; 0.61 | — |
Eligibility Criteria
Inclusion Criteria
- Have a clinical diagnosis of Huntington Disease (HD) with chorea
- Be able to walk, with or without the assistance of a person or device
- Participants of childbearing potential who do not practice total abstinence must agree to use hormonal or two forms of nonhormonal contraception (dual contraception) consistently while participating in the study until 30 days (females) or 90 days (males) after the last dose of the study drug
- Be able to read and understand English
Exclusion Criteria
- Have a history of previously established therapy with a VMAT2 inhibitor, in the judgement of the investigator
- Have difficulty swallowing
- Are currently pregnant or breastfeeding
- Have a known history of long QT syndrome, cardiac tachyarrhythmia, left bundle-branch block, atrioventricular block, uncontrolled bradyarrhythmia, or heart failure
- Have an unstable or serious medical or psychiatric illness
- Have a significant risk of suicidal behavior
- Have a history of substance dependence or substance (drug) or alcohol abuse, within 1 year of screening
- If taking antidepressant therapy, be on a stable regimen
- Have received gene therapy at any time
- Have received an investigational drug in a clinical study within 30 days of the baseline visit or plan to use such investigational drug (other than valbenazine) during the study
- Have had a blood loss ≥550 milliliters (mL) or donated blood within 30 days before the baseline visit
- Had a medically significant illness within 30 days before baseline, or any history of neuroleptic malignant syndrome
Data sourced from ClinicalTrials.gov (NCT04102579) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.