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Completed

NCT Number: NCT04102579

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

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.

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Key information

Conditions

Chorea, Huntington Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Chorea Cognition Disorders Congenital, Hereditary, and Neonatal Diseases and Abnormalities Dementia Dyskinesias Genetic Diseases, Inborn Heredodegenerative Disorders, Nervous System Huntington Disease Mental Disorders Movement Disorders Nervous System Diseases Neurocognitive Disorders Neurodegenerative Diseases Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Neurocrine Clinical Site, Vancouver, British Columbia, Canada

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Valbenazine

Drug

vesicular monoamine transporter 2 (VMAT2) inhibitor

Other names: NBI-98854

Placebo

Drug

non-active dosage form

Primary outcomes

  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)

    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 outcomes

  1. Percent of Clinical Global Impression of Change (CGI-C) Responders at Week 12

    Time frame: 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.

  2. Percent of Patient Global Impression of Change (PGI-C) Responders at Week 12

    Time frame: 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.

  3. Change From Baseline to Week 12 in the Quality of Life in Neurological Disorders (Neuro-QoL) Upper Extremity Function T-Score

    Time frame: 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.

  4. Change From Baseline to Week 12 in the Neuro-QoL Lower Extremity Function T-Score

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Neurocrine Biosciences

Industry

Collaborators

  • Huntington Study Group

Registry information

Official study title

A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy, Safety, and Tolerability of Valbenazine for the Treatment of Chorea Associated With Huntington Disease

Acronym: KINECT-HD

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Sep 25, 2019
Registry last updated
Oct 11, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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