Long-term Study to Evaluate Safety and Tolerability of Valbenazine in Participants With Chorea As… (NCT06312189) | Clinical Trial Compass
By InvitationPhase 3
Long-term Study to Evaluate Safety and Tolerability of Valbenazine in Participants With Chorea Associated With Huntington Disease in Canada
Canada7 participantsStarted 2024-04-24
Plain-language summary
This study will evaluate long-term safety and tolerability of valbenazine in participants with chorea associated with Huntington Disease (HD) who participated in Study NBI-98854-HD3006 (NCT04400331) in Canada.
Who can participate
Age range
18 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.
Key Inclusion Criteria:
* Participated in Study NBI-98854-HD3006 and completing dosing through the Week 156 visit; or were actively participating, receiving study treatment, and completed an early termination visit Study NBI-98854-HD3006 at the time of the study closure at sites in Canada.
* 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.
Key Exclusion Criteria:
* Have difficulty swallowing
* Are currently pregnant or breastfeeding
* Have a medically significant abnormality, physical examination finding, clinically significant laboratory abnormality
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 long-term safety study focused on tracking adverse events in people with Huntington's disease-related chorea, what kinds of side effects have come up with valbenazine so far, and how might those affect someone at my stage of the disease?
2This trial is enrolling by invitation only in Canada — am I or my loved one the kind of patient who might be considered for an invitation, and what would need to be true about my situation to be eligible?
3Because the main thing being measured here is how many participants experience treatment-related side effects over the long term, does that mean there's still uncertainty about the safety profile of valbenazine, and how does that compare to already-approved options for Huntington's chorea?
4What does committing to a long-term study actually look like in practice — how often would I need to come in, and is that realistic given where we are with managing the disease day to day?
5Is there a standard treatment for Huntington's-related chorea that I should consider first before thinking about a research study like this one, or does this trial fill a gap that existing treatments don't address?
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)