Purpose

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

Eligibility

Eligible Ages
Between 18 Years and 75 Years
Eligible Genders
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 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

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
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

Recruiting Locations

Neurocrine Clinical Site
Birmingham, Alabama 35233

Neurocrine Clinical Site
Little Rock, Arkansas 72205

Neurocrine Clinical Site
La Jolla, California 92037

Neurocrine Clinical Site
Sacramento, California 95817

Neurocrine Clinical Site
Aurora, Colorado 80045

Neurocrine Clinical Site
Englewood, Colorado 80113

Neurocrine Clinical Site
Washington, District of Columbia 20007

Neurocrine Clinical Site
Gainesville, Florida 32608

Neurocrine Clinical Site
Miami, Florida 33136

Neurocrine Clinical Site
Atlanta, Georgia 30329

Neurocrine Clinical Site
Chicago, Illinois 60611

Neurocrine Clinical Site
Chicago, Illinois 60612

Neurocrine Clinical Site
Indianapolis, Indiana 46202

Neurocrine Clinical Site
Kansas City, Kansas 66160

Neurocrine Clinical Site
Wichita, Kansas 67226

Neurocrine Clinical Site
Boston, Massachusetts 02118

Neurocrine Clinical Site
Boston, Massachusetts 02215

Neurocrine Clinical Site
Ann Arbor, Michigan 48105

Neurocrine Clinical Site
Omaha, Nebraska 68198

Neurocrine Clinical Site
Rochester, New York 14618

Neurocrine Clinical Site
Durham, North Carolina 27705

Neurocrine Clinical Site
Fargo, North Dakota 58103

Neurocrine Clnical Site
Columbus, Ohio 43210

Neurocrine Clinical Site
Pittsburgh, Pennsylvania 15213

Neurocrine Clinical Site
Columbia, South Carolina 29203

Neurocrine Clinical Site
Nashville, Tennessee 37212

Neurocrine Clinical Site
Houston, Texas 77054

Neurocrine Clinical Site
Seattle, Washington 98195

Neurocrine Clinical Site
Spokane, Washington 33202

More Details

NCT ID
NCT04102579
Status
Recruiting
Sponsor
Neurocrine Biosciences

Study Contact

Cheryl Chen
858-617-7744
cechen@neurocrine.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.