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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
Results First Posted : October 11, 2023
Last Update Posted : October 11, 2023
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 participants 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

Resource links provided by the National Library of Medicine

Drug Information available for: Valbenazine

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 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 Outcome Measures :
  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.



Information from the National Library of Medicine

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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. 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
  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 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 milliliters (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
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United States, Alabama
Neurocrine Clinical Site
Birmingham, Alabama, United States, 35233
United States, Arkansas
Neurocrine Clinical Site
Little Rock, Arkansas, United States, 72205
United States, California
Neurocrine Clinical Site
La Jolla, California, United States, 92037
Neurocrine Clinical Site
Sacramento, California, United States, 95817
United States, Colorado
Neurocrine Clinical Site
Aurora, Colorado, United States, 80045
Neurocrine Clinical Site
Englewood, Colorado, United States, 80113
United States, District of Columbia
Neurocrine Clinical Site
Washington, District of Columbia, United States, 20007
United States, Florida
Neurocrine Clinical Site
Gainesville, Florida, United States, 32608
Neurocrine Clinical Site
Miami, Florida, United States, 33136
United States, Georgia
Neurocrine Clinical Site
Atlanta, Georgia, United States, 30329
United States, Illinois
Neurocrine Clinical Site
Chicago, Illinois, United States, 60611
Neurocrine Clinical Site
Chicago, Illinois, United States, 60612
United States, Indiana
Neurocrine Clinical Site
Indianapolis, Indiana, United States, 46202
United States, Iowa
Neurocrine Clinical Site
Iowa City, Iowa, United States, 52242
United States, Kansas
Neurocrine Clinical Site
Kansas City, Kansas, United States, 66160
Neurocrine Clinical Site
Wichita, Kansas, United States, 67226
United States, Kentucky
Neurocrine Clinical Site
Louisville, Kentucky, United States, 40202
United States, Louisiana
Neurocrine Clinical Site
New Orleans, Louisiana, United States, 70121
United States, Massachusetts
Neurocrine Clinical Site
Boston, Massachusetts, United States, 02118
Neurocrine Clinical Site
Boston, Massachusetts, United States, 02215
Neurocrine Clinical Site
Charlestown, Massachusetts, United States, 02129
United States, Michigan
Neurocrine Clinical Site
Ann Arbor, Michigan, United States, 48109
Neurocrine Clinical Site
West Bloomfield, Michigan, United States, 48322
United States, Nebraska
Neurocrine Clinical Site
Omaha, Nebraska, United States, 68198
United States, New York
Neurocrine Clinical Site
Rochester, New York, United States, 14618
Neurocrine Clinical Site
Williamsville, New York, United States, 14221
United States, North Carolina
Neurocrine Clinical Site
Durham, North Carolina, United States, 27705
United States, North Dakota
Neurocrine Clinical Site
Fargo, North Dakota, United States, 58103
United States, Ohio
Neurocrine Clinical Site
Cleveland, Ohio, United States, 44195
Neurocrine Clinical Site
Columbus, Ohio, United States, 43210
Neurocrine Clinical Site
Toledo, Ohio, United States, 43614
United States, Pennsylvania
Neurocrine Clinical Site
Pittsburgh, Pennsylvania, United States, 15213
United States, South Carolina
Neurocrine Clinical Site
Charleston, South Carolina, United States, 29425
Neurocrine Clinical Site
Columbia, South Carolina, United States, 29203
Neurocrine Clinical Site
Greenville, South Carolina, United States, 29615
United States, Tennessee
Neurocrine Clinical Site
Nashville, Tennessee, United States, 37212
United States, Texas
Neurocrine Clinical Site
Houston, Texas, United States, 77054
United States, Utah
Neurocrine Clinical Site
Salt Lake City, Utah, United States, 84108
United States, Vermont
Neurocrine Clinical Site
Burlington, Vermont, United States, 05401
United States, Virginia
Neurocrine Clinical Site
Charlottesville, Virginia, United States, 22908
United States, Washington
Neurocrine Clinical Site
Seattle, Washington, United States, 98195
Neurocrine Clinical Site
Spokane, Washington, United States, 99202
Canada, British Columbia
Neurocrine Clinical Site
Vancouver, British Columbia, Canada, V6T 2B5
Canada, Ontario
Neurocrine Clinical Site
Ottawa, Ontario, Canada, K1Y 4E9
Neurocrine Clinical Site
Toronto, Ontario, Canada, M2K 1E1
Neurocrine Clinical Site
Toronto, Ontario, Canada, M3B 2S7
Sponsors and Collaborators
Neurocrine Biosciences
Huntington Study Group
Investigators
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Study Director: Chief Medical Officer Chief Medical Officer
  Study Documents (Full-Text)

Documents provided by Neurocrine Biosciences:
Study Protocol  [PDF] April 12, 2021
Statistical Analysis Plan  [PDF] November 19, 2021

Additional Information:
Publications of Results:
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
Results First Posted: October 11, 2023
Last Update Posted: October 11, 2023
Last Verified: September 2023
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
Keywords provided by Neurocrine Biosciences:
Huntington's
Huntington
Chorea
Movement disorder
Valbenazine
HD
Tetrabenazine
VMAT2-Inhibitor
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