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Valbenazine for Huntington's Disease
Study Summary
This trial will study the long-term safety and effectiveness of a drug for treating Huntington disease.
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Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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- I have lost more than 550 mL of blood or donated blood in the last 30 days.I have a history of heart rhythm problems or heart failure.I haven't taken any experimental drugs (except valbenazine) in the last 30 days.I have not used VMAT2 inhibitors in the last 30 days.You have had problems with drugs or alcohol in the past year.I haven't had a serious illness in the last month and no history of severe reaction to antipsychotic drugs.I have received gene therapy.Did not participate in Study NBI-98854-HD3005.I can walk, even if I need help or a device.I have trouble swallowing.I meet at least one of the required conditions for inclusion.You have a high risk of thinking about or attempting to harm yourself.I have had severe liver problems or specific blood issues during a previous study.I have Huntington's Disease with chorea, can walk, read English, consent to participate, and will use contraception if applicable.You are allergic to any ingredient in valbenazine.I do not have any serious or unstable health or mental conditions.
- Group 1: Valbenazine
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
Can people who are not yet 50 years old join this clinical trial?
"This study requires that all participants are between 18-75 years old."
Has Valbenazine's safety been verified by the FDA?
"Valbenazine's safety is estimated to be a 3. This judgement comes from the fact that this medication is in Phase 3 trials, meaning that there is both evidence of its efficacy and multiple rounds of data supporting its safety."
How many people are included in this research project?
"That is correct. The information available on clinicaltrials.gov attests that this trial is still actively looking for subjects. This particular study was first posted on September 18th, 2020 and was most recently edited on October 31st, 2022. In total, they are looking to have 150 participants at 33 locations across the country."
What are the ideal characteristics for participants of this clinical trial?
"To be eligible for this study, participants must have Huntington's disease, be aged 18-75, and meet either requirement #1 or #2. Additionally, candidates must be able to walk unassisted or with the help of a mobility device. Those who have participated in Study NBI-98854-HD3005 are ineligible."
Are researchers looking for more participants for this trial?
"The trial is currently seeking patients, according to the information on clinicaltrials.gov. This study was first posted on September 18th 2020 and was most recently updated on October 31st 2022."
Has a study like this been done before?
"Valbenazine has been under investigation since 2020. The first study was a Phase 1 clinical trial sponsored by Neurocrine Biosciences. After the initial success in 2020, which involved 150 participants, Valbenazine received approval for Phase 3 trials. Currently, there are 3 live trials taking place across 52 cities in 2 countries."
What other research has been conducted on Valbenazine?
"Valbenazine was first studied in 2020 by Neurocrine, and since then there have been 19 completed clinical trials. As of now, 3 more studies are underway with active recruitment. These trials are primarily based out of Toronto, Canada."
Does this trial have a broad reach in Canada?
"33 clinical trial sites are currently operational. These locations include major cities such as Toronto, Omaha and Chicago. There may be a location near you, which would reduce travel time if you decided to participate in this study."
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