Summary

Eligibility
for people ages 18-75 (full criteria)
Location
at Sacramento, California and other locations
Dates
study started
estimated completion

Description

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.

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

Keywords

Chorea, Huntington Huntington Disease Chorea Valbenazine

Eligibility

You can join if…

Open to people ages 18-75

  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 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

You CAN'T join if...

  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 (AV) 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 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

Locations

  • Neurocrine Clinical Site
    Sacramento California 95817 United States
  • Neurocrine Clinical Site
    La Jolla California 92037 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Neurocrine Biosciences
Links
Study website Sign up for this study
ID
NCT04102579
Phase
Phase 3
Study Type
Interventional
Last Updated