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

Sponsor
Neurocrine Biosciences (Industry)
Overall Status
Completed
CT.gov ID
NCT04102579
Collaborator
Huntington Study Group (Other)
128
Enrollment
46
Locations
2
Arms
23.4
Actual Duration (Months)
2.8
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

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
Phase 3

Study Design

Study Type:
Interventional
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 :
Nov 13, 2019
Actual Primary Completion Date :
Oct 15, 2021
Actual Study Completion Date :
Oct 26, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: Valbenazine

Capsule, administered orally once daily for 12 weeks.

Drug: Valbenazine
vesicular monoamine transporter 2 (VMAT2) inhibitor
Other Names:
  • NBI-98854

    		•
    Placebo Comparator: Placebo

    Capsule, administered orally once daily for 12 weeks.

    Drug: Placebo
    non-active dosage form

    Outcome Measures

    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. [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 [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 [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 [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 [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).

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 75 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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 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 (AV) 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 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Neurocrine Clinical Site Birmingham Alabama United States 35233
    2 Neurocrine Clinical Site Little Rock Arkansas United States 72205
    3 Neurocrine Clinical Site La Jolla California United States 92037
    4 Neurocrine Clinical Site Sacramento California United States 95817
    5 Neurocrine Clinical Site Aurora Colorado United States 80045
    6 Neurocrine Clinical Site Englewood Colorado United States 80113
    7 Neurocrine Clinical Site Washington District of Columbia United States 20007
    8 Neurocrine Clinical Site Gainesville Florida United States 32608
    9 Neurocrine Clinical Site Miami Florida United States 33136
    10 Neurocrine Clinical Site Atlanta Georgia United States 30329
    11 Neurocrine Clinical Site Chicago Illinois United States 60611
    12 Neurocrine Clinical Site Chicago Illinois United States 60612
    13 Neurocrine Clinical Site Indianapolis Indiana United States 46202
    14 Neurocrine Clinical Site Iowa City Iowa United States 52242
    15 Neurocrine Clinical Site Kansas City Kansas United States 66160
    16 Neurocrine Clinical Site Wichita Kansas United States 67226
    17 Neurocrine Clinical Site Louisville Kentucky United States 40202
    18 Neurocrine Clinical Site New Orleans Louisiana United States 70121
    19 Neurocrine Clinical Site Boston Massachusetts United States 02118
    20 Neurocrine Clinical Site Boston Massachusetts United States 02215
    21 Neurocrine Clinical Site Charlestown Massachusetts United States 02129
    22 Neurocrine Clinical Site Ann Arbor Michigan United States 48109
    23 Neurocrine Clinical Site West Bloomfield Michigan United States 48322
    24 Neurocrine Clinical Site Omaha Nebraska United States 68198
    25 Neurocrine Clinical Site Rochester New York United States 14618
    26 Neurocrine Clinical Site Williamsville New York United States 14221
    27 Neurocrine Clinical Site Durham North Carolina United States 27705
    28 Neurocrine Clinical Site Fargo North Dakota United States 58103
    29 Neurocrine Clinical Site Cleveland Ohio United States 44195
    30 Neurocrine Clnical Site Columbus Ohio United States 43210
    31 Neurocrine Clinical Site Toledo Ohio United States 43614
    32 Neurocrine Clinical Site Pittsburgh Pennsylvania United States 15213
    33 Neurocrine Clinical Site Charleston South Carolina United States 29425
    34 Neurocrine Clinical Site Columbia South Carolina United States 29203
    35 Neurocrine Clinical Site Greenville South Carolina United States 29615
    36 Neurocrine Clinical Site Nashville Tennessee United States 37212
    37 Neurocrine Clinical Site Houston Texas United States 77054
    38 Neurocrine Clinical Site Salt Lake City Utah United States 84108
    39 Neurocrine Clinical Site Burlington Vermont United States 05401
    40 Neurocrine Clinical Site Charlottesville Virginia United States 22908
    41 Neurocrine Clinical Site Seattle Washington United States 98195
    42 Neurocrine Clinical Site Spokane Washington United States 99202
    43 Neurocrine Clinical Site Vancouver British Columbia Canada V6T 2B5
    44 Neurocrine Clinical Site Ottawa Ontario Canada K1Y 4E9
    45 Neurocrine Clinical Site Toronto Ontario Canada M2K 1E1
    46 Neurocrine Clinical Site Toronto Ontario Canada M3B 2S7

    Sponsors and Collaborators

    • Neurocrine Biosciences
    • Huntington Study Group

    Investigators

    • Study Director: Chief Medical Officer, Chief Medical Officer

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Neurocrine Biosciences
    ClinicalTrials.gov Identifier:
    NCT04102579
    Other Study ID Numbers:
    • NBI-98854-HD3005
    First Posted:
    Sep 25, 2019
    Last Update Posted:
    Dec 15, 2021
    Last Verified:
    Dec 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Huntington Disease
    Chorea

    Study Results

    No Results Posted as of Dec 15, 2021