Efficacy, Safety, and Tolerability of Valbenazine for the Treatment of Chorea Associated With Huntington Disease
NCT ID: NCT04102579
Last Updated: 2023-10-11
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
128 participants
INTERVENTIONAL
2019-11-13
2021-10-26
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Valbenazine
Capsule, administered orally once daily for 12 weeks.
Valbenazine
vesicular monoamine transporter 2 (VMAT2) inhibitor
Placebo
Capsule, administered orally once daily for 12 weeks.
Placebo
non-active dosage form
Interventions
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Valbenazine
vesicular monoamine transporter 2 (VMAT2) inhibitor
Placebo
non-active dosage form
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
75 Years
ALL
No
Sponsors
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Huntington Study Group
NETWORK
Neurocrine Biosciences
INDUSTRY
Responsible Party
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Principal Investigators
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Chief Medical Officer
Role: STUDY_DIRECTOR
Chief Medical Officer
Locations
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Neurocrine Clinical Site
Toronto, Ontario, Canada
Neurocrine Clinical Site
Toronto, Ontario, Canada
Neurocrine Clinical Site
Birmingham, Alabama, United States
Neurocrine Clinical Site
Little Rock, Arkansas, United States
Neurocrine Clinical Site
La Jolla, California, United States
Neurocrine Clinical Site
Sacramento, California, United States
Neurocrine Clinical Site
Aurora, Colorado, United States
Neurocrine Clinical Site
Englewood, Colorado, United States
Neurocrine Clinical Site
Washington D.C., District of Columbia, United States
Neurocrine Clinical Site
Gainesville, Florida, United States
Neurocrine Clinical Site
Miami, Florida, United States
Neurocrine Clinical Site
Atlanta, Georgia, United States
Neurocrine Clinical Site
Chicago, Illinois, United States
Neurocrine Clinical Site
Chicago, Illinois, United States
Neurocrine Clinical Site
Indianapolis, Indiana, United States
Neurocrine Clinical Site
Iowa City, Iowa, United States
Neurocrine Clinical Site
Kansas City, Kansas, United States
Neurocrine Clinical Site
Wichita, Kansas, United States
Neurocrine Clinical Site
Louisville, Kentucky, United States
Neurocrine Clinical Site
New Orleans, Louisiana, United States
Neurocrine Clinical Site
Boston, Massachusetts, United States
Neurocrine Clinical Site
Boston, Massachusetts, United States
Neurocrine Clinical Site
Charlestown, Massachusetts, United States
Neurocrine Clinical Site
Ann Arbor, Michigan, United States
Neurocrine Clinical Site
West Bloomfield, Michigan, United States
Neurocrine Clinical Site
Omaha, Nebraska, United States
Neurocrine Clinical Site
Rochester, New York, United States
Neurocrine Clinical Site
Williamsville, New York, United States
Neurocrine Clinical Site
Durham, North Carolina, United States
Neurocrine Clinical Site
Fargo, North Dakota, United States
Neurocrine Clinical Site
Cleveland, Ohio, United States
Neurocrine Clinical Site
Columbus, Ohio, United States
Neurocrine Clinical Site
Toledo, Ohio, United States
Neurocrine Clinical Site
Pittsburgh, Pennsylvania, United States
Neurocrine Clinical Site
Charleston, South Carolina, United States
Neurocrine Clinical Site
Columbia, South Carolina, United States
Neurocrine Clinical Site
Greenville, South Carolina, United States
Neurocrine Clinical Site
Nashville, Tennessee, United States
Neurocrine Clinical Site
Houston, Texas, United States
Neurocrine Clinical Site
Salt Lake City, Utah, United States
Neurocrine Clinical Site
Burlington, Vermont, United States
Neurocrine Clinical Site
Charlottesville, Virginia, United States
Neurocrine Clinical Site
Seattle, Washington, United States
Neurocrine Clinical Site
Spokane, Washington, United States
Neurocrine Clinical Site
Vancouver, British Columbia, Canada
Neurocrine Clinical Site
Ottawa, Ontario, Canada
Countries
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References
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Furr Stimming E, Claassen DO, Kayson E, Goldstein J, Mehanna R, Zhang H, Liang GS, Haubenberger D; Huntington Study Group KINECT-HD Collaborators. 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. Lancet Neurol. 2023 Jun;22(6):494-504. doi: 10.1016/S1474-4422(23)00127-8.
Rodrigues FB, Wild EJ. Huntington's Disease Clinical Trials Corner: April 2020. J Huntingtons Dis. 2020;9(2):185-197. doi: 10.3233/JHD-200002.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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NBI-98854-HD3005
Identifier Type: -
Identifier Source: org_study_id
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