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

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 participants with Huntington disease.

Condition

  • Chorea, Huntington

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. 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

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

More Details

NCT ID
NCT04102579
Status
Completed
Sponsor
Neurocrine Biosciences