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 |
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Recruitment Status :
Completed
First Posted : September 25, 2019
Last Update Posted : October 5, 2022
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Sponsor:
Neurocrine Biosciences
Collaborator:
Huntington Study Group
Information provided by (Responsible Party):
Neurocrine Biosciences
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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 |
| Study Type : | Interventional (Clinical Trial) |
| 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 : | November 13, 2019 |
| Actual Primary Completion Date : | October 15, 2021 |
| Actual Study Completion Date : | October 26, 2021 |
Resource links provided by the National Library of Medicine
MedlinePlus related topics:
Huntington's Disease
Drug Information available for:
Valbenazine
| Arm | Intervention/treatment |
|---|---|
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Experimental: Valbenazine
Capsule, administered orally once daily for 12 weeks.
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Drug: Valbenazine
vesicular monoamine transporter 2 (VMAT2) inhibitor
Other Name: NBI-98854 |
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Placebo Comparator: Placebo
Capsule, administered orally once daily for 12 weeks.
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Drug: Placebo
non-active dosage form |
Primary Outcome Measures :
- 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 :
- 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).
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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:
- Have a clinical diagnosis of Huntington Disease (HD) with chorea
- Be able to walk, with or without the assistance of a person or device
- 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
- Be able to read and understand English
Exclusion Criteria:
- Have a history of previously established therapy with a VMAT2 inhibitor, in the judgement of the investigator
- Have difficulty swallowing
- Are currently pregnant or breastfeeding
- Have a known history of long QT syndrome, cardiac tachyarrhythmia, left bundle-branch block, atrioventricular (AV) block, uncontrolled bradyarrhythmia, or heart failure
- Have an unstable or serious medical or psychiatric illness
- Have a significant risk of suicidal behavior
- Have a history of substance dependence or substance (drug) or alcohol abuse, within 1 year of screening
- If taking antidepressant therapy, be on a stable regimen
- Have received gene therapy at any time
- 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
- Have had a blood loss ≥550 mL or donated blood within 30 days before the baseline visit
- Had a medically significant illness within 30 days before baseline, or any history of neuroleptic malignant syndrome
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
Locations
Show 46 study locations
Sponsors and Collaborators
Neurocrine Biosciences
Huntington Study Group
Investigators
| Study Director: | Chief Medical Officer | Chief Medical Officer |
Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| 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: | October 5, 2022 |
| Last Verified: | September 2022 |
| Individual Participant Data (IPD) Sharing Statement: | |
| 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:
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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 |