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Trial record 6 of 20 for:    valbenazine

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

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ClinicalTrials.gov Identifier: NCT04102579
Recruitment Status : Recruiting
First Posted : September 25, 2019
Last Update Posted : November 4, 2019
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's 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's Disease
Estimated Study Start Date : November 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's 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, Kansas
Neurocrine Clinical Site Recruiting
Wichita, Kansas, United States, 67226
Sponsors and Collaborators
Neurocrine Biosciences
Huntington Study Group
Investigators
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Study Director: Chief Medical Officer Chief Medical Officer

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Responsible Party: Neurocrine Biosciences
ClinicalTrials.gov Identifier: NCT04102579     History of Changes
Other Study ID Numbers: NBI-98854-HD3005
First Posted: September 25, 2019    Key Record Dates
Last Update Posted: November 4, 2019
Last Verified: October 2019
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
Signs and Symptoms
Tetrabenazine
Adrenergic Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Adrenergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs