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Efficacy, Safety, and Tolerability of Valbenazine for the Treatment of Chorea Associated With Huntington Disease (KINECT-HD)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04102579
Recruitment Status : Completed
First Posted : September 25, 2019
Last Update Posted : December 15, 2021
Sponsor:
Collaborator:
Huntington Study Group
Information provided by (Responsible Party):
Neurocrine Biosciences

Brief 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 subjects with Huntington disease.

Condition or disease Intervention/treatment Phase
Chorea, Huntington Drug: Valbenazine Drug: Placebo Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 128 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official 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
Actual Study Start Date : November 13, 2019
Actual Primary Completion Date : October 15, 2021
Actual Study Completion Date : October 26, 2021


Arm Intervention/treatment
Experimental: Valbenazine
Capsule, administered orally once daily for 12 weeks.
Drug: Valbenazine
vesicular monoamine transporter 2 (VMAT2) inhibitor
Other Name: NBI-98854

Placebo Comparator: Placebo
Capsule, administered orally once daily for 12 weeks.
Drug: Placebo
non-active dosage form




Primary Outcome Measures :
  1. Change from Baseline (average of Screening and Day -1) to Maintenance (average of Weeks 10 and 12) in the Unified Huntington's Disease Rating Scale (UHDRS) Total Maximal Chorea (TMC) Score. [ Time Frame: Screening, Day -1, Week 10, and Week 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 score indicates improvement in chorea.


Secondary Outcome Measures :
  1. Clinical Global Impression of Change (CGI-C) Response Status at Week 12 [ Time Frame: Week 12 ]
    The CGI-C is a 7-point Likert scale that rates the overall global improvement of chorea since the initiation of study drug dosing, ranging from 1 (very much improved) to 7 (very much worse), as assessed by the clinician. Subjects whose CGI-C score is either a 1 ("very much improved") or a 2 ("much improved") will be classified as responders.

  2. Patient Global Impression of Change (PGI-C) Response Status at Week 12 [ Time Frame: Week 12 ]
    The PGI-C is a 7-point Likert scale that rates the overall global improvement of chorea since the initiation of study drug dosing, ranging from 1 (very much improved) to 7 (very much worse), as assessed by the subject. Subjects whose PGI-C score is either a 1 ("very much improved") or a 2 ("much improved") will be classified as responders.

  3. Change from Baseline to Week 12 in the Quality of Life in Neurological Disorders (Neuro-QoL) Upper Extremity Function [ Time Frame: Day -1 and 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).

  4. Change from Baseline to Week 12 in the Neuro-QoL Lower Extremity Function [ Time Frame: Day -1 and 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).



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Have a clinical diagnosis of Huntington Disease (HD) with chorea
  2. Be able to walk, with or without the assistance of a person or device
  3. Subjects 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
  4. Be able to read and understand English

Exclusion Criteria:

  1. Have a history of previously established therapy with a VMAT2 inhibitor, in the judgement of the investigator
  2. Have difficulty swallowing
  3. Are currently pregnant or breastfeeding
  4. Have a known history of long QT syndrome, cardiac tachyarrhythmia, left bundle-branch block, atrioventricular (AV) block, uncontrolled bradyarrhythmia, or heart failure
  5. Have an unstable or serious medical or psychiatric illness
  6. Have a significant risk of suicidal behavior
  7. Have a history of substance dependence or substance (drug) or alcohol abuse, within 1 year of screening
  8. If taking antidepressant therapy, be on a stable regimen
  9. Have received gene therapy at any time
  10. 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
  11. Have had a blood loss ≥550 mL or donated blood within 30 days before the baseline visit
  12. Had a medically significant illness within 30 days before baseline, or any history of neuroleptic malignant syndrome

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04102579


Locations
Show Show 46 study locations
Sponsors and Collaborators
Neurocrine Biosciences
Huntington Study Group
Investigators
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Study Director: Chief Medical Officer Chief Medical Officer
Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Neurocrine Biosciences
ClinicalTrials.gov Identifier: NCT04102579    
Other Study ID Numbers: NBI-98854-HD3005
First Posted: September 25, 2019    Key Record Dates
Last Update Posted: December 15, 2021
Last Verified: December 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Huntington Disease
Chorea
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Dementia
Dyskinesias
Movement Disorders
Heredodegenerative Disorders, Nervous System
Neurodegenerative Diseases
Genetic Diseases, Inborn
Cognition Disorders
Neurocognitive Disorders
Mental Disorders
Neurologic Manifestations