Your session is about to expire
← Back to Search
Vesicular Monoamine Transporter 2 (VMAT2) Inhibitor
Deutetrabenazine for Huntington's Disease
Phase 2 & 3
Recruiting
Led By Amy E Brown, MD
Research Sponsored by Vanderbilt University Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Montreal Cognitive Assessment score ≥ 22 on screening
Diagnosis of HD with documented CAG repeat ≥ 37
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 10 weeks
Awards & highlights
Study Summary
This trial will look at whether the drug deutetrabenazine can improve speech and gait in people with movement disorders.
Who is the study for?
This trial is for individuals with Huntington's Disease who can walk at least 10 meters, have a certain level of chorea (involuntary movements), and are cognitively able to participate. They must not be pregnant or breastfeeding, have severe depression or speech impairments, nor any serious medical conditions that could interfere with the study.Check my eligibility
What is being tested?
The trial is testing Deutetrabenazine to see if it improves functional speech and walking in people with Huntington's Disease. Participants will receive this medication and their speech and gait dynamics will be monitored for changes.See study design
What are the potential side effects?
Deutetrabenazine may cause side effects such as sleepiness, restlessness, agitation, nausea, dry mouth, and potentially worsen mood disorders like depression.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My cognitive function score is 22 or higher.
Select...
I have Huntington's disease with a CAG repeat of 37 or more.
Select...
I can walk 10 meters without help.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 10 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 10 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Motor Speech Evaluation (MSE)
Sentence Intelligibility Test (SIT)
Secondary outcome measures
3-D optical motion capture system recording
Four Square Step Test (FSST)
Functional Gait Assessment (FGA)
+1 moreOther outcome measures
10 Meter Walk test
Communication Effectiveness Survey
Health Status
+2 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: DeutetrabenazineExperimental Treatment1 Intervention
The mode of administration is oral. Subjects will be started on deutetrabenazine at a dose of 6mg/day. Dosing will be up-titrated in increments of 6mg/day per week to achieve optimal chorea control.
Find a Location
Who is running the clinical trial?
Vanderbilt University Medical CenterLead Sponsor
857 Previous Clinical Trials
672,163 Total Patients Enrolled
Teva Branded Pharmaceutical Products R&D, Inc.Industry Sponsor
251 Previous Clinical Trials
3,485,346 Total Patients Enrolled
Amy E Brown, MDPrincipal Investigator - Vanderbilt University Medical Center
Vanderbilt University Medical Center
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have completed at least 10th grade.My cognitive function score is 22 or higher.I do not have any serious or unstable health or mental conditions.I have severe difficulty speaking or cannot speak at all.I have Huntington's disease with a CAG repeat of 37 or more.You have a history of trying to harm yourself.I agree to use birth control from the start to the end of the study.I can walk 10 meters without help.I am not pregnant or breastfeeding.I have kidney or liver problems.You cannot swallow the study medication.I do not have severe depression or thoughts of harming myself.You have a high score for involuntary movements called chorea.Your heart's electrical activity (EKG) shows a QTcF measurement of more than 500 milliseconds.You have had problems with drinking or using drugs in the past year.I am currently taking medication for movement disorders.
Research Study Groups:
This trial has the following groups:- Group 1: Deutetrabenazine
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- 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
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Does Deutetrabenazine have a history of being an effective medication?
"At this time, there are 5 clinical studies underway that are investigating Deutetrabenazine. Out of those 5, 2 are in Phase 3. The majority of the trials for Deutetrabenazine are situated in Philadelphia, but it is being studied at 70 different research centres in total."
Answered by AI
Have medical researchers done this kind of study before?
"As of right now, there are 5 ongoing clinical trials for Deutetrabenazine in 11 different countries and 21 cities. The first study was conducted in 2020 by Teva Branded Pharmaceutical Products R&D, Inc. In this Phase 3 drug approval stage study, 45 patients were observed. Since then, 9 more trials have been completed."
Answered by AI
Can people with the required health qualifications enroll in this clinical trial right now?
"Yes, this clinical trial is still recruiting patients, as of December 26th, 2021. The study was first posted on November 19th, 2021."
Answered by AI
Who else is applying?
How old are they?
18 - 65
What site did they apply to?
Vanderbilt University Medical Center
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger