Open-Label Rollover Study for Continuing Valbenazine Administration for the Treatment of Chorea Associated With Huntington Disease

Overview

This is a Phase 3, open-label study to evaluate the long-term safety and tolerability of valbenazine, and to provide subjects continued access to valbenazine for the treatment of chorea associated with Huntington disease.

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: July 2023

Interventions

  • Drug: Valbenazine
    • vesicular monoamine transporter 2 (VMAT2) inhibitor

Arms, Groups and Cohorts

  • Experimental: Valbenazine
    • Capsule, administered orally once daily.

Clinical Trial Outcome Measures

Primary Measures

  • Number of Participants with Treatment-Emergent Adverse Events (TEAEs)
    • Time Frame: Up to 104 weeks

Secondary Measures

  • Change from Baseline in the Unified Huntington’s Disease Rating Scale (UHDRS) Total Maximal Chorea (TMC) Score
    • Time Frame: Up to 104 weeks
    • 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 score indicates improvement in chorea.

Participating in This Clinical Trial

Inclusion Criteria

1. Have participated in and completed treatment in Study NBI-98854-HD3005

2. 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.

Exclusion Criteria

1. Are currently pregnant or breastfeeding

2. Have difficulty swallowing

3. Have a known history of long QT syndrome, cardiac tachyarrhythmia, left bundle-branch block, atrioventricular (AV) block, uncontrolled bradyarrhythmia, or heart failure

4. Have an unstable or serious medical or psychiatric illness

5. Have a significant risk of suicidal behavior

6. Have current substance dependence or substance (drug) or alcohol abuse

7. Have received gene therapy at any time

8. Have received an investigational drug (other than valbenazine) within 30 days before the baseline visit or plan to use an investigational drug (other than valbenazine) during the study

9. Have had a blood loss ≥550 mL or donated blood within 30 days before the baseline visit

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 75 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Neurocrine Biosciences
  • Collaborator
    • Huntington Study Group
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Chief Medical Officer, Study Director, Chief Medical Officer

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