Active not recruitingPHASE3INTERVENTIONAL

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

This study is designed to learn more about the long-term safety and how well a medication called valbenazine works for people living with Huntington's disease. Specifically, it focuses on helping to control the involuntary, dance-like movements known as chorea, which can be a key symptom of Huntington's. Participants who were in a previous study with valbenazine may be able to continue taking it, as can some new participants who meet certain health and mobility requirements. The study aims to provide ongoing access to this treatment and observe its effects over an extended period. This is a chance to help researchers understand more about managing Huntington's symptoms for the future.

At a glance

Status

Active not recruiting

Phase

PHASE3

Sponsor

Neurocrine Biosciences

Enrolment target

154

Start

18 Sep 2020

Estimated completion

01 Mar 2026

Chorea, Huntington

What is this study about?

This study is looking into a medicine called valbenazine, which is used to help people with Huntington's disease who have involuntary movements known as chorea. Chorea can make it hard to do everyday things, so finding treatments that help manage these movements is really important. This particular study is about understanding how safe valbenazine is and how well it continues to work over a long period.

The study offers people who have already been taking valbenazine in a previous study the chance to continue receiving it. This helps researchers see the effects of the medicine over a much longer time than typical studies. It also provides an opportunity for some new participants to start taking valbenazine, if they meet certain criteria for the study.

By taking part, you would be helping doctors and scientists gather more valuable information about this medication. This information is crucial for understanding how to best support people living with Huntington's disease and improve their quality of life in the long run. Your participation could make a real difference in advancing our knowledge of how to manage chorea.

Key takeaways

This study is for people with Huntington's disease and chorea.
It tests the long-term safety and effectiveness of valbenazine.
You might be eligible if you were in a previous study or meet new criteria.
You'll receive regular medical check-ups and the study medication.
Your participation helps advance understanding of Huntington's disease treatment.

Who may be eligible?

To join this study, you generally need to be between 18 and 75 years old. There are two main ways people can become eligible. Firstly, if you have already taken part in a specific previous study about valbenazine (called NBI-98854-HD3005) and completed it, you might be able to continue with this new study. Even if you left that study early due to COVID-19 related reasons, you could still be eligible.

Secondly, if you didn't participate in that previous study, you might still be able to join. For this, you need to have a clear diagnosis of Huntington's disease with chorea, confirmed by your doctor and genetic tests. You also need to be able to walk, which can include using aids like a walking stick or a person to help you.

There are also some health conditions that would prevent you from joining. For example, if you have severe trouble swallowing, are currently pregnant or breastfeeding, or have certain serious heart problems, you wouldn't be able to take part. Also, if you have a history of serious mental health issues that put you at risk of self-harm, or if you've recently used certain other study medicines, you wouldn't be eligible. Women who could become pregnant must agree to use effective contraception throughout the study and for a short time afterwards.

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.

Are you between 18 and 75 years old?
Do you have a diagnosis of Huntington's disease with chorea?
Can you walk, possibly with help?
Are you able to understand and follow study instructions (in English)?
Are you currently not pregnant or breastfeeding?
Do you not have certain serious heart or swallowing problems?

Answer every question to see your result.

What does participation involve?

If you join this study, you would continue to take the medicine valbenazine. The study is designed to run for a long time, potentially up to an extra 104 weeks (about two years) after the initial study period. You would have regular visits to the clinic where study staff would check on your health, how well the medicine is working, and if you're experiencing any side effects. They might also do some tests. The specific schedule of these visits and what happens at each one would be fully explained to you. You would be given the medication and monitored closely throughout your time in the study.

Potential risks and benefits

Taking part in this study may offer some potential benefits, such as continued access to valbenazine, which could help manage your chorea symptoms. You would also receive close medical attention and monitoring from the study team. However, like all medications, valbenazine can have side effects, and some people might not find it helpful. There's also the chance that the study procedures or tests could be uncomfortable or have small risks. It's very important to remember that participating in any clinical study is always voluntary, and you have the right to withdraw at any time, for any reason, without it affecting your usual medical care.

Locations (34)

Neurocrine Clinical Site
Verified postcode
Birmingham, United States
Neurocrine Clinical Site
Verified postcode
Little Rock, United States
Neurocrine Clinical Site
Verified postcode
La Jolla, United States
Neurocrine Clinical Site
Verified postcode
Aurora, United States
Neurocrine Clinical Site
Verified postcode
Washington D.C., United States
Neurocrine Clinical Site
Verified postcode
Boca Raton, United States
Neurocrine Clinical Site
Verified postcode
Gainesville, United States
Neurocrine Clinical Site
Verified postcode
Atlanta, United States
Neurocrine Clinical Site
Verified postcode
Chicago, United States
Neurocrine Clinical Site
Verified postcode
Chicago, United States
Neurocrine Clinical Site
Verified postcode
Indianapolis, United States
Neurocrine Clinical Site
Verified postcode
Iowa City, United States

Common questions

What is chorea?

Chorea refers to involuntary, jerky, dance-like movements that can affect different parts of the body, often seen in people with Huntington's disease.

What is valbenazine?

Valbenazine is a medication being studied for its potential to help control chorea in people with Huntington's disease.

How long will the study last?

For participants in the US, the study could last up to an additional 104 weeks (about two more years) after an initial study period. For Canadian participants, there's an option to join a separate, similar study.

Do I have to pay to be in the study?

Generally, study medications and procedures directly related to the research are provided at no cost, but you should confirm this with the study team.

What if I experience side effects?

The study team will monitor you closely for any side effects, and you should always report any new or worsening symptoms to them immediately.