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

Chorea, Huntington Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04400331
• Other study ID #: NBI-98854-HD3006
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: September 18, 2020
• Est. completion date: March 2026

Study information

• Verified date: December 2023
• Source: Neurocrine Biosciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

After completion of Week 156/early termination visit, participants in the US will be given the option to continue into an extended maintenance period for up to 104 weeks and participants in Canada will have the option to participate in a separate open-label study (Study NBI-98854-HD3022).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 154
• Est. completion date: March 2026
• Est. primary completion date: March 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

Either #1 or #2 must be met for inclusion eligibility.

1. Have participated in Study NBI-98854-HD3005 and a. Study drug dosing completion of Study NBI-98854-HD3005, as demonstrated by completed study drug dosing through the follow-up visit or early terminated Study NBI-98854-HD3005 for administrative reasons due to COVID-19 (for example, site closure related to COVID-19)

2. Did not participate in Study NBI-98854-HD3005 and

1. Have a clinical and genetic diagnosis of Huntington Disease (HD) with chorea

2. Be able to walk, with or without the assistance of a person or device

3. Be able to read and understand English and capable of providing consent to study participation or have a legally authorized representative providing consent and the participant providing assent

4. Participants of childbearing potential must agree to use contraception consistently while participating in the study until 30 days after last dose of the study treatment

Exclusion Criteria:

1. Have difficulty swallowing

2. Are currently pregnant or breastfeeding

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 a history of substance dependence or substance (drug) or alcohol abuse, within 1 year of screening

7. Have received gene therapy at any time

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

10. Have a history of severe hepatic impairment or history of protocol specified hematologic abnormalities during the course of the NBI-98854-HD3005 study

11. Had a medically significant illness within 30 days before baseline, or any history of neuroleptic malignant syndrome

12. Have a known hypersensitivity to any component of the formulation of valbenazine

13. For participants who did not participate in NBI-98854-HD3005: have a history of VMAT2 inhibitor use within 30 days of baseline

Related Conditions & MeSH terms

• Chorea
• Chorea, Huntington
• Huntington Disease

Intervention

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

Locations

Country	Name	City	State
Canada	Neurocrine Clinical Site	Ottawa	Ontario
Canada	Neurocrine Clinical Site	Toronto	Ontario
Canada	Neurocrine Clinical Site	Vancouver	British Columbia
United States	Neurocrine Clinical Site	Ann Arbor	Michigan
United States	Neurocrine Clinical Site	Atlanta	Georgia
United States	Neurocrine Clinical Site	Aurora	Colorado
United States	Neurocrine Clinical Site	Birmingham	Alabama
United States	Neurocrine Clinical Site	Boca Raton	Florida
United States	Neurocrine Clinical Site	Boston	Massachusetts
United States	Neurocrine Clinical Site	Burlington	Vermont
United States	Neurocrine Clinical Site	Charleston	South Carolina
United States	Neurocrine Clinical Site	Charlestown	Massachusetts
United States	Neurocrine Clinical Site	Chicago	Illinois
United States	Neurocrine Clinical Site	Chicago	Illinois
United States	Neurocrine Clinical Site	Columbia	South Carolina
United States	Neurocrine Clinical Site	Columbus	Ohio
United States	Neurocrine Clinical Site	Durham	North Carolina
United States	Neurocrine Clinical Site	Gainesville	Florida
United States	Neurocrine Clinical Site	Greenville	South Carolina
United States	Neurocrine Clinical Site	Houston	Texas
United States	Neurocrine Clinical Site	Indianapolis	Indiana
United States	Neurocrine Clinical Site	Iowa City	Iowa
United States	Neurocrine Clinical Site	La Jolla	California
United States	Neurocrine Clinical Site	Little Rock	Arkansas
United States	Neurocrine Clinical Site	Louisville	Kentucky
United States	Neurocrine Clinical Site	Nashville	Tennessee
United States	Neurocrine Clinical Site	New Orleans	Louisiana
United States	Neurocrine Clinical Site	Omaha	Nebraska
United States	Neurocrine Clinical Site	Pittsburgh	Pennsylvania
United States	Neurocrine Clinical Site	Rochester	New York
United States	Neurocrine Clinical Site	Toledo	Ohio
United States	Neurocrine Clinical Site	Washington	District of Columbia
United States	Neurocrine Clinical Site	Wichita	Kansas
United States	Neurocrine Clinical Site	Williamsville	New York

Sponsors (2)

Lead Sponsor	Collaborator
Neurocrine Biosciences	Huntington Study Group

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants with Treatment-Emergent Adverse Events (TEAEs)		Up to 262 weeks
Secondary	Change from Baseline in the Unified Huntington's Disease Rating Scale (UHDRS) Total Maximal Chorea (TMC) Score	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.	Up to 262 weeks

External Links

•   Study website