Chorea, HuntingtonPhase 3KINECT-HDNCT04102579
Efficacy, Safety, and Tolerability of Valbenazine for the Treatment of Chorea Associated With Huntington Disease
A Phase 3 study testing Valbenazine in people with Chorea, Huntington, run by Neurocrine Biosciences at 46 sites in 2 countries.
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Chorea, Huntington
- What is being tested?
- Valbenazine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 128 participants
- Where
- 46 sitesin 2 countries
- Study dates
- 13 Nov 2019to 26 Oct 2021
- Phase
- Phase 3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Have a clinical diagnosis of Huntington Disease (HD) with chorea
- Be able to walk, with or without the assistance of a person or device
- 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
- Be able to read and understand English
Who cannot join
- 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 block, uncontrolled bradyarrhythmia, or heart failure
- Have an unstable or serious medical or psychiatric illness
- Have a significant risk of suicidal behavior
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- 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 milliliters (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
Trial locations and contacts
46 sites in 2 countries.
46 sites in 2 countries
United States42 sites
Neurocrine Clinical Site
Ann Arbor, Michigan, 48109
Neurocrine Clinical Site
Atlanta, Georgia, 30329
Neurocrine Clinical Site
Aurora, Colorado, 80045
Neurocrine Clinical Site
Birmingham, Alabama, 35233
Neurocrine Clinical Site
Boston, Massachusetts, 02118
Neurocrine Clinical Site
Boston, Massachusetts, 02215
Neurocrine Clinical Site
Burlington, Vermont, 05401
Neurocrine Clinical Site
Charleston, South Carolina, 29425
Neurocrine Clinical Site
Charlestown, Massachusetts, 02129
Neurocrine Clinical Site
Charlottesville, Virginia, 22908
Neurocrine Clinical Site
Chicago, Illinois, 60611
Neurocrine Clinical Site
Chicago, Illinois, 60612
Neurocrine Clinical Site
Cleveland, Ohio, 44195
Neurocrine Clinical Site
Columbia, South Carolina, 29203
Neurocrine Clinical Site
Columbus, Ohio, 43210
Neurocrine Clinical Site
Durham, North Carolina, 27705
Neurocrine Clinical Site
Englewood, Colorado, 80113
Neurocrine Clinical Site
Fargo, North Dakota, 58103
Neurocrine Clinical Site
Gainesville, Florida, 32608
Neurocrine Clinical Site
Greenville, South Carolina, 29615
Neurocrine Clinical Site
Houston, Texas, 77054
Neurocrine Clinical Site
Indianapolis, Indiana, 46202
Neurocrine Clinical Site
Iowa City, Iowa, 52242
Neurocrine Clinical Site
Kansas City, Kansas, 66160
Neurocrine Clinical Site
La Jolla, California, 92037
Neurocrine Clinical Site
Little Rock, Arkansas, 72205
Neurocrine Clinical Site
Louisville, Kentucky, 40202
Neurocrine Clinical Site
Miami, Florida, 33136
Neurocrine Clinical Site
Nashville, Tennessee, 37212
Neurocrine Clinical Site
New Orleans, Louisiana, 70121
Neurocrine Clinical Site
Omaha, Nebraska, 68198
Neurocrine Clinical Site
Pittsburgh, Pennsylvania, 15213
Neurocrine Clinical Site
Rochester, New York, 14618
Neurocrine Clinical Site
Sacramento, California, 95817
Neurocrine Clinical Site
Salt Lake City, Utah, 84108
Neurocrine Clinical Site
Seattle, Washington, 98195
Neurocrine Clinical Site
Spokane, Washington, 99202
Neurocrine Clinical Site
Toledo, Ohio, 43614
Neurocrine Clinical Site
Washington D.C., District of Columbia, 20007
Neurocrine Clinical Site
West Bloomfield, Michigan, 48322
Neurocrine Clinical Site
Wichita, Kansas, 67226
Neurocrine Clinical Site
Williamsville, New York, 14221
Canada4 sites
Neurocrine Clinical Site
Ottawa, Ontario, K1Y 4E9
Neurocrine Clinical Site
Toronto, Ontario, M2K 1E1
Neurocrine Clinical Site
Toronto, Ontario, M3B 2S7
Neurocrine Clinical Site
Vancouver, British Columbia, V6T 2B5
About this study
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
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.
- Conditions
- Chorea, Huntington
- Being tested
- Valbenazine, Placebo
- Keywords
- Huntington's, Huntington, Chorea, Movement disorder, Valbenazine, HD, Tetrabenazine, VMAT2-Inhibitor
- Medical subject headings
- Huntington Disease, Chorea, Movement Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ValbenazineDrug
Also called NBI-98854
vesicular monoamine transporter 2 (VMAT2) inhibitor
PlaceboDrug
non-active dosage form
| Study group | Role | What they receive |
|---|---|---|
| Valbenazine | Experimental | Capsule, administered orally once daily for 12 weeks. Receives: Drug: Valbenazine |
| Placebo | Placebo comparator | Capsule, administered orally once daily for 12 weeks. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline (average of screening and Day -1), maintenance (average of Weeks 10 and 12)
Secondary outcomes (4)
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.
Measured: Week 12
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.
Measured: Week 12
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.
Measured: Baseline, Week 12
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.
Measured: Baseline, Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2019
- Study start13 Nov 2019
- Primary completion15 Oct 2021
- Study completion26 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Chorea, HuntingtonStudies of the same condition, open and under way.
- More trials run by Neurocrine BiosciencesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 128 participants (actual)
Sponsor and investigators
- Lead sponsor
- Neurocrine Biosciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Huntington Study Group
- Responsible party
- Sponsor
- Investigators
- Chief Medical Officer, Study director, Chief Medical Officer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04102579
- Sponsor's protocol ID
- NBI-98854-HD3005
- Acronym
- KINECT-HD
- Status last verified
- Sep 2023
- First submitted
- 23 Sep 2019
- Last updated
- 11 Oct 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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-HD): a phase 3, randomised, double-blind, placebo-controlled trial. Lancet Neurol. 2023 Jun;22(6):494-504. doi: 10.1016/S1474-4422(23)00127-8.
PubMed 37210099Rodrigues FB, Wild EJ. Huntington's Disease Clinical Trials Corner: April 2020. J Huntingtons Dis. 2020;9(2):185-197. doi: 10.3233/JHD-200002.
PubMed 32250312