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

• Status: Active, not recruiting
• Trial end date: 2021-09-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Neurocrine Biosciences
• Collaborator: Huntington Study Group
• Treatments: Tetrabenazine

Criteria

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 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 (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