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

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ClinicalTrials.gov Identifier: NCT04102579
Recruitment Status : Recruiting
First Posted : September 25, 2019
Last Update Posted : February 1, 2021
Sponsor:
Collaborator:
Huntington Study Group
Information provided by (Responsible Party):
Neurocrine Biosciences

Tracking Information
First Submitted Date  ICMJE September 23, 2019
First Posted Date  ICMJE September 25, 2019
Last Update Posted Date February 1, 2021
Actual Study Start Date  ICMJE November 13, 2019
Estimated Primary Completion Date March 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 23, 2019)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 23, 2019)
  • 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.
  • 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.
  • 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).
  • 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).
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy, Safety, and Tolerability of Valbenazine for the Treatment of Chorea Associated With Huntington Disease
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Chorea, Huntington
Intervention  ICMJE
  • Drug: Valbenazine
    vesicular monoamine transporter 2 (VMAT2) inhibitor
    Other Name: NBI-98854
  • Drug: Placebo
    non-active dosage form
Study Arms  ICMJE
  • Experimental: Valbenazine
    Capsule, administered orally once daily for 12 weeks.
    Intervention: Drug: Valbenazine
  • Placebo Comparator: Placebo
    Capsule, administered orally once daily for 12 weeks.
    Intervention: Drug: Placebo
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: September 23, 2019)
120
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE March 2021
Estimated Primary Completion Date March 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Cheryl Chen 858-617-7744 cechen@neurocrine.com
Listed Location Countries  ICMJE Canada,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04102579
Other Study ID Numbers  ICMJE NBI-98854-HD3005
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Neurocrine Biosciences
Study Sponsor  ICMJE Neurocrine Biosciences
Collaborators  ICMJE Huntington Study Group
Investigators  ICMJE
Study Director: Chief Medical Officer Chief Medical Officer
PRS Account Neurocrine Biosciences
Verification Date January 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP