Long-term Study to Evaluate Safety and Tolerability of Valbenazine in Participants With Chorea Associated With Huntington Disease in Canada
This research is specifically looking at how safe a medicine called valbenazine is over a long time for people living in Canada who have Huntington's disease and experience uncontrolled, jerky movements (chorea). It's an extension study for participants who have already taken part in a previous research trial known as Study NBI-98854-HD3006. The main goal is to understand if valbenazine continues to be well-tolerated and safe when used for longer periods. This helps doctors and patients make informed decisions about its long-term use for managing chorea associated with Huntington's disease.
At a glance
What is this study about?
This study is about a medicine called valbenazine, which is being investigated for people who have Huntington's disease, specifically to help with the jerky, uncontrolled movements known as chorea. Huntington's disease is a condition that affects the brain and can cause a wide range of symptoms, including these movements. While medicines can help manage some symptoms, doctors are always looking for the safest and most effective options for long-term use.
The main purpose of this particular study is to check the long-term safety of valbenazine. It's designed for people in Canada who have already taken part in an earlier study involving this medicine. By continuing to observe participants over a longer period, doctors can gather important information about any potential side effects or issues that might only appear with extended use. This helps ensure the medicine is safe for people to take over many months or even years.
Understanding a medicine's long-term safety is very important. It allows healthcare professionals to have a clearer picture of how a treatment affects people's health over time. This information is crucial for deciding if a medicine is a good choice for someone to use for a long period to manage their condition effectively and safely.
Key takeaways
- This study is for people in Canada with Huntington's disease and chorea.
- It's looking at the long-term safety of a medicine called valbenazine.
- Only people who were in a previous study (NBI-98854-HD3006) can join.
- Participation involves ongoing use of the study medicine and regular health check-ups.
- You can stop participating at any time.
- The goal is to understand how safe valbenazine is over a long period.
Who may be eligible?
To be able to join this study, you must have already taken part in a previous study with valbenazine called NBI-98854-HD3006. This means you either completed the dosing phase of that study up to its final visit (Week 156), or you were actively receiving the study medicine when that previous study closed in specific Canadian locations.
Also, if you are a woman who could become pregnant, you would need to agree to use effective birth control consistently throughout your time in this study and for 30 days after taking your last dose of the study medicine.
You would not be able to join if you have trouble swallowing, are currently pregnant or breastfeeding, or if doctors find any other significant health problems or abnormal test results that they believe would make it unsafe for you to participate.
Could this study suit you?
Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.
- Have I already participated in Study NBI-98854-HD3006 in Canada?
- If I can become pregnant, am I willing to use effective birth control throughout the study and for 30 days afterwards?
- Do I have any problems with swallowing?
- Am I currently pregnant or breastfeeding?
- Have I been told by my doctor that I have any other significant health problems that might prevent my participation?
What does participation involve?
If you decide to take part in this study, the doctors and nurses will regularly check on your health and how you are responding to the valbenazine medicine. You will continue to take the study medicine as directed. The study team will schedule visits to see you, which will involve check-ups, some questions about how you're feeling, and possibly some tests to monitor your health. They will also record any side effects you might experience. The exact number and frequency of visits, along with the total duration of your participation, will be explained to you fully by the study team, but it's designed to observe the long-term effects of the medicine.
Potential risks and benefits
Locations (3)
- Neurocrine Clinical SiteVerified postcodeVancouver, Canada
- Neurocrine Clinical SiteVerified postcodeOttawa, Canada
- Neurocrine Clinical SiteVerified postcodeToronto, Canada
Common questions
What is chorea?
Chorea refers to involuntary, irregular, unpredictable muscle movements that can appear to flow from one body part to another. It's a common symptom in Huntington's disease.
What is valbenazine?
Valbenazine is a medicine being studied to help control the involuntary movements (chorea) linked to Huntington's disease. This study is looking at its long-term safety.
Do I have to pay to be in the study?
No, you do not have to pay to participate in the study. All study-related medication and assessments will be provided at no cost to you.
Can I leave the study if I change my mind?
Yes, you can choose to leave the study at any time and for any reason. Your decision will not affect your usual medical care.
What happens after the study ends?
The study team will discuss with you what happens after your participation, which may include further follow-up or discussions about your ongoing treatment options with your doctor.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
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