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

NCT04102579 · KINECT-HD Phase 3Completed

Lead sponsor
Neurocrine Biosciences (Industry)
Enrollment
128 (actual)
Start date
13 Nov 2019
Primary completion
15 Oct 2021 (actual)
Study completion
26 Oct 2021
Last update posted
11 Oct 2023

Design

Study type
Interventional
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel
Masking
Quadruple
Arms
2

Interventions

  • Valbenazine Drug
  • Placebo Drug

Conditions and primary outcome

  • Chorea, Huntington

Primary outcome

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))

Posted results on ClinicalTrials.gov

Source: ClinicalTrials.gov results for NCT04102579 (opens in a new tab)· Licence: public-domain

First posted · Last update posted · Imported from ClinicalTrials.gov download 2026-10-25

Primary outcomes with a statistical analysis

  1. Change From Screening Period Baseline to Maintenance Period in the Unified Huntington's Disease Rating Scale (UHDRS) Total Maximal Chorea (TMC) Score.

    Time frame
    Baseline (average of screening and Day -1), maintenance (average of Weeks 10 and 12)
    Measure
    Least squares mean
    Unit
    units on a scale

    • Valbenazine vs PlaceboOther

      Results were analyzed using a mixed-effect model repeated measures (MMRM) analysis. The model included the screening period baseline TMC as a covariate, and treatment group, visit, treatment group-by-visit interaction, and baseline-by-visit interaction as fixed effects. Participant was included as a random effect.

      Estimate
      -3.16Least Squares (LS) Means Difference
      95% CI, two-sided
      -4.37 to -1.95
      p-value
      <0.0001
      Method
      MMRM

Serious adverse events

Time frame: Day 1 (after dosing) through Week 14

Participants with serious adverse events per group for KINECT-HD, as posted
GroupAffectedAt risk
Valbenazine164
Placebo263

Posted results as ClinicalTrials.gov prints them: primary outcome analyses and serious adverse event totals only. Registry facts, not reviewed by HealthTrade and not investment advice; filing-derived results are listed separately.

Source: ClinicalTrials.gov, U.S. National Library of Medicine. Listing a study does not mean NLM has evaluated it.

Results from company and journal sources

No editor-confirmed results are on record for this study.

Publications

2 on PubMed

  1. 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.

    The Lancet. Neurology · 2023 Jun

    PubMed 37210099 (opens in a new tab)DOI 10.1016/S1474-4422(23)00127-8 (opens in a new tab)

  2. Huntington's Disease Clinical Trials Corner: April 2020.

    Journal of Huntington's disease · 2020

    PubMed 32250312 (opens in a new tab)DOI 10.3233/JHD-200002 (opens in a new tab)

Citations from PubMed, U.S. National Library of Medicine; abstracts are not stored. A publication lists this study’s NCT number and may be a review that cites many studies.

CT-VCA trial quality

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Data integrity

Compare what the registry, company releases, FDA documents and publications say about this study.

Drugs on HealthTrade

Source

Source: ClinicalTrials.gov, U.S. National Library of Medicine. Listing a study does not mean NLM has evaluated it.

Nothing on this page is medical or investment advice.