Open-Label Rollover Study for Continuing Valbenazine Administration for the Treatment of Chorea A… (NCT04400331) | Clinical Trial Compass
CompletedPhase 3
Open-Label Rollover Study for Continuing Valbenazine Administration for the Treatment of Chorea Associated With Huntington Disease
United States, Canada154 participantsStarted 2020-09-18
Plain-language 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.
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Have participated in Study NBI-98854-HD3005 and
. 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 participation or have a legally authorized representative providing consent and the participant providing assent
. 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
. 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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Since this is a Phase 3 rollover study that has already completed, would my doctor be able to share what the safety data showed — specifically what kinds of treatment-emergent adverse events participants experienced while taking valbenazine for Huntington's chorea?
2This trial was an open-label study, meaning everyone received valbenazine rather than a placebo — does that change how we should interpret what we know about its safety and effectiveness compared to a blinded, controlled trial?
3Since the study has completed, is valbenazine now approved or available as a standard treatment for Huntington's chorea, and if so, would that be a better path for me than looking for an active clinical trial?
4Huntington's disease affects daily functioning over time — based on the results from this study, does my doctor think the long-term use of valbenazine is a realistic option worth considering given where I am in my disease progression?
5Because this was a rollover study — meaning participants had already been in an earlier valbenazine trial — does my doctor know whether the safety findings would apply to someone who is new to this medication rather than already experienced with it?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Number of Participants with Treatment-Emergent Adverse Events (TEAEs)
. 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