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Trial record 1 of 1 for:    NCT04102579
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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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04102579
Recruitment Status : Recruiting
First Posted : September 25, 2019
Last Update Posted : July 27, 2020
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)
Estimated Enrollment : 120 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
Estimated Primary Completion Date : March 2021
Estimated Study Completion Date : March 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).



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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 during the screening, treatment and follow-up periods of the study
  4. Be able to read and understand English

Exclusion Criteria:

  1. Have a history of prior VMAT2 inhibitor therapy
  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, bradycardia (<60 bpm), or heart failure
  5. Have an unstable or serious medical or psychiatric illness
  6. Have a significant risk of suicidal behavior
  7. Have current substance dependence or substance (drug) or alcohol abuse
  8. If taking antidepressant therapy, be on a stable regimen
  9. Have received gene therapy at any time
  10. Have received an investigational drug within 30 days before the baseline visit or plan to use an 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

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


Contacts
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Contact: Cheryl Chen 858-617-7744 cechen@neurocrine.com

Locations
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United States, California
Neurocrine Clinical Site Recruiting
La Jolla, California, United States, 92037
United States, Colorado
Neurocrine Clinical Site Recruiting
Aurora, Colorado, United States, 80045
Neurocrine Clinical Site Recruiting
Englewood, Colorado, United States, 80113
United States, Florida
Neurocrine Clinical Site Recruiting
Miami, Florida, United States, 33136
United States, Georgia
Neurocrine Clinical Site Recruiting
Atlanta, Georgia, United States, 30329
United States, Illinois
Neurocrine Clinical Site Recruiting
Chicago, Illinois, United States, 60611
Neurocrine Clinical Site Recruiting
Chicago, Illinois, United States, 60612
United States, Indiana
Neurocrine Clinical Site Recruiting
Indianapolis, Indiana, United States, 46202
United States, Kansas
Neurocrine Clinical Site Recruiting
Kansas City, Kansas, United States, 66160
Neurocrine Clinical Site Recruiting
Wichita, Kansas, United States, 67226
United States, Massachusetts
Neurocrine Clinical Site Recruiting
Boston, Massachusetts, United States, 02118
Neurocrine Clinical Site Recruiting
Boston, Massachusetts, United States, 02215
United States, Michigan
Neurocrine Clinical Site Recruiting
Ann Arbor, Michigan, United States, 48105
United States, Nebraska
Neurocrine Clinical Site Recruiting
Omaha, Nebraska, United States, 68198
United States, New York
Neurocrine Clinical Site Recruiting
Rochester, New York, United States, 14618
United States, North Carolina
Neurocrine Clinical Site Recruiting
Durham, North Carolina, United States, 27705
United States, Ohio
Neurocrine Clnical Site Recruiting
Columbus, Ohio, United States, 43210
United States, Pennsylvania
Neurocrine Clinical Site Recruiting
Pittsburgh, Pennsylvania, United States, 15213
United States, South Carolina
Neurocrine Clinical Site Recruiting
Columbia, South Carolina, United States, 29203
United States, Tennessee
Neurocrine Clinical Site Recruiting
Nashville, Tennessee, United States, 37212
United States, Texas
Neurocrine Clinical Site Recruiting
Houston, Texas, United States, 77054
United States, Washington
Neurocrine Clinical Site Recruiting
Seattle, Washington, United States, 98195
Neurocrine Clinical Site Recruiting
Spokane, Washington, United States, 33202
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: July 27, 2020
Last Verified: July 2020
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