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

  • STATUS
    Recruiting
  • End date
    Jul 27, 2023
  • participants needed
    150
  • sponsor
    Neurocrine Biosciences
Updated on 27 April 2022
valbenazine

Summary

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.

Details
Condition Chorea, Huntington
Treatment Valbenazine
Clinical Study IdentifierNCT04400331
SponsorNeurocrine Biosciences
Last Modified on27 April 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Either #1 or #2 must be met for inclusion eligibility
Have participated in Study NBI-98854-HD3005 and
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 (eg, site closure related to COVID-19)
Did not participate in Study NBI-98854-HD3005 and
Have a clinical and genetic diagnosis of Huntington Disease (HD) with chorea
Be able to walk, with or without the assistance of a person or device
Be able to read and understand English and capable of providing consent to study
Subjects of childbearing potential must agree to use contraception consistently while participating in the study until 30 days after last dose of the study treatment
participation or have a legally authorized representative providing consent
and the subject providing assent

Exclusion Criteria

Have difficulty swallowing
Are currently pregnant or breastfeeding
Have a known history of long QT syndrome, cardiac tachyarrhythmia, left bundle-branch block, atrioventricular (AV) block, uncontrolled bradyarrhythmia, or heart failure
Have an unstable or serious medical or psychiatric illness
Have a significant risk of suicidal behavior
Have a history of substance dependence or substance (drug) or alcohol abuse, within 1 year of screening
Have received gene therapy at any time
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
Have a history of severe hepatic impairment or history of protocol specified hematologic abnormalities during the course of the NBI-98854-HD3005 study
Had a medically significant illness within 30 days before baseline, or any history of neuroleptic malignant syndrome
Have had a blood loss ≥550 mL or donated blood within 30 days before the baseline visit
For subjects who did not participate in NBI-98854-HD3005: have a history of VMAT2 inhibitor use within 30 days of baseline
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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