Efficacy, Safety, and Tolerability of Valbenazine for the Treatment of Chorea Associated With Huntington Disease

Chorea, Huntington Clinical Trial

— KINECT-HD  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04102579
• Other study ID #: NBI-98854-HD3005
• Status: Completed
• Phase: Phase 3
• Start date: November 13, 2019
• Est. completion date: October 26, 2021

Study information

• Verified date: September 2023
• Source: Neurocrine Biosciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 participants with Huntington disease.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 128
• Est. completion date: October 26, 2021
• Est. primary completion date: October 15, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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. 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:

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 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

Related Conditions & MeSH terms

• Chorea
• Chorea, Huntington
• Huntington Disease

Intervention

Drug:
• Valbenazine
vesicular monoamine transporter 2 (VMAT2) inhibitor
• Placebo
non-active dosage form

Locations

Country	Name	City	State
Canada	Neurocrine Clinical Site	Ottawa	Ontario
Canada	Neurocrine Clinical Site	Toronto	Ontario
Canada	Neurocrine Clinical Site	Toronto	Ontario
Canada	Neurocrine Clinical Site	Vancouver	British Columbia
United States	Neurocrine Clinical Site	Ann Arbor	Michigan
United States	Neurocrine Clinical Site	Atlanta	Georgia
United States	Neurocrine Clinical Site	Aurora	Colorado
United States	Neurocrine Clinical Site	Birmingham	Alabama
United States	Neurocrine Clinical Site	Boston	Massachusetts
United States	Neurocrine Clinical Site	Boston	Massachusetts
United States	Neurocrine Clinical Site	Burlington	Vermont
United States	Neurocrine Clinical Site	Charleston	South Carolina
United States	Neurocrine Clinical Site	Charlestown	Massachusetts
United States	Neurocrine Clinical Site	Charlottesville	Virginia
United States	Neurocrine Clinical Site	Chicago	Illinois
United States	Neurocrine Clinical Site	Chicago	Illinois
United States	Neurocrine Clinical Site	Cleveland	Ohio
United States	Neurocrine Clinical Site	Columbia	South Carolina
United States	Neurocrine Clinical Site	Columbus	Ohio
United States	Neurocrine Clinical Site	Durham	North Carolina
United States	Neurocrine Clinical Site	Englewood	Colorado
United States	Neurocrine Clinical Site	Fargo	North Dakota
United States	Neurocrine Clinical Site	Gainesville	Florida
United States	Neurocrine Clinical Site	Greenville	South Carolina
United States	Neurocrine Clinical Site	Houston	Texas
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	La Jolla	California
United States	Neurocrine Clinical Site	Little Rock	Arkansas
United States	Neurocrine Clinical Site	Louisville	Kentucky
United States	Neurocrine Clinical Site	Miami	Florida
United States	Neurocrine Clinical Site	Nashville	Tennessee
United States	Neurocrine Clinical Site	New Orleans	Louisiana
United States	Neurocrine Clinical Site	Omaha	Nebraska
United States	Neurocrine Clinical Site	Pittsburgh	Pennsylvania
United States	Neurocrine Clinical Site	Rochester	New York
United States	Neurocrine Clinical Site	Sacramento	California
United States	Neurocrine Clinical Site	Salt Lake City	Utah
United States	Neurocrine Clinical Site	Seattle	Washington
United States	Neurocrine Clinical Site	Spokane	Washington
United States	Neurocrine Clinical Site	Toledo	Ohio
United States	Neurocrine Clinical Site	Washington	District of Columbia
United States	Neurocrine Clinical Site	West Bloomfield	Michigan
United States	Neurocrine Clinical Site	Wichita	Kansas
United States	Neurocrine Clinical Site	Williamsville	New York

Sponsors (2)

Lead Sponsor	Collaborator
Neurocrine Biosciences	Huntington Study Group

Countries where clinical trial is conducted

United States,  Canada, 

References & Publications (1)

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- — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change From Screening Period Baseline to Maintenance Period in the Unified Huntington's Disease Rating Scale (UHDRS) Total Maximal Chorea (TMC) Score.	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 TMC scores indicates improvement in chorea symptoms.	Baseline (average of screening and Day -1), maintenance (average of Weeks 10 and 12)
Secondary	Percent of Clinical Global Impression of Change (CGI-C) Responders at Week 12	The CGI-C is a 7-point scale that rates the overall global change in chorea symptoms since the initiation of study drug dosing, ranging from 1 (very much improved) to 7 (very much worse), as assessed by the investigator or qualified clinician designee.; Participants whose CGI-C score was either a 1 (very much improved) or a 2 (much improved) were classified as responders.	Week 12
Secondary	Percent of Patient Global Impression of Change (PGI-C) Responders at Week 12	The PGI-C is a 7-point scale that rates the overall global change in chorea symptoms since the initiation of study drug dosing, ranging from 1 (very much improved) to 7 (very much worse), as assessed by the participant.; Participants whose PGI-C score was either a 1 (very much improved) or a 2 (much improved) were classified as responders.	Week 12
Secondary	Change From Baseline to Week 12 in the Quality of Life in Neurological Disorders (Neuro-QoL) Upper Extremity Function T-Score	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). The Neuro-QoL scores were standardized as T-scores with a mean of 50 and standard deviation of 10. Scores below 50 indicated below average upper extremity function. The change from baseline to Week 12 in the Neuro-QoL Upper Extremity Function T-score are presented here. An increase in score indicates increased function.	Baseline, Week 12
Secondary	Change From Baseline to Week 12 in the Neuro-QoL Lower Extremity Function T-Score	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). The Neuro-QoL scores were standardized as T-scores with a mean of 50 and standard deviation of 10. Scores below 50 indicated below average upper extremity function. The change from baseline to Week 12 in the Neuro-QoL Upper Extremity Function T-score are presented here. An increase in score indicates better function.	Baseline, Week 12

External Links

•   Study website