Your session is about to expire
← Back to Search
Vesicular Monoamine Transporter 2 (VMAT2) Inhibitor
AUSTEDO for Dystonia (AUDYT Trial)
Phase 1 & 2
Waitlist Available
Research Sponsored by University of Pennsylvania
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 months
Awards & highlights
AUDYT Trial Summary
This trial is testing the safety and effectiveness of AUSTEDO in people with dystonia. The study will last up to 13 weeks, and participants will be monitored for side effects throughout.
Who is the study for?
Adults over 18 with confirmed dystonia, able to understand English and consent, on stable CNS medication for at least a month can join. They must not be pregnant and agree to use contraception. Excluded are those with Parkinson's, certain mental health issues, recent botulinum toxin treatment or specific drug use.Check my eligibility
What is being tested?
The trial tests Deutetrabenazine (AUSTEDO) in adults with dystonia for safety and effectiveness over up to 13 weeks. Starting at 12 mg/day, the dose increases weekly until side effects limit it or reaching a maximum of either 48 mg/day or lower if on CYP2D6 inhibitors.See study design
What are the potential side effects?
Possible side effects include dose-limiting reactions that could affect how much medicine participants can tolerate. ECG changes may occur; monitoring will track any potential heart rhythm problems as well as signs of parkinsonism.
AUDYT Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 3 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Proportion of study subjects able to titrate up to the maximum tolerated dose
Secondary outcome measures
Change in Cognition
Change in Daytime Somnolence
Change in Dystonia Severity
+3 moreAUDYT Trial Design
1Treatment groups
Experimental Treatment
Group I: Intervention arm - Oral DeutetrabenazineExperimental Treatment1 Intervention
This is the only arm for this trial. All subjects will receive oral Deutetrabanazine.
Find a Location
Who is running the clinical trial?
University of PennsylvaniaLead Sponsor
2,002 Previous Clinical Trials
42,880,984 Total Patients Enrolled
Teva Branded Pharmaceutical Products R&D, Inc.Industry Sponsor
251 Previous Clinical Trials
3,485,361 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a history of bipolar disorder, major depression, or currently have active depression.You have been diagnosed with schizophrenia or related disorders in the past.I have been on a stable dose of my brain-related medication for at least 30 days.I am 18 or older and can give my consent to participate.I haven't taken specific medications like antipsychotics or stimulants in the last 30 days.I took medication that might have caused my muscle contractions before they started.Participants have a Mini-Mental State Examination (MMSE) score of more than 24.I have a history of kidney problems.You have been diagnosed with definite dystonia by a specialist in movement disorders.I am not pregnant and use birth control.I have been diagnosed with Parkinson's or a similar movement disorder.You have a history of trying to hurt yourself on purpose or thinking about hurting yourself, or you are currently thinking about hurting yourself.My dystonia is confirmed to be dopa-responsive by genetic testing.I have a history of significant liver disease.My heart's electrical activity is within a safe range, and I have no history of irregular heartbeats.I do not have any unstable medical conditions.I haven't had botulinum toxin injections in the last 11 weeks.I have a neurological condition that might affect dystonia evaluations.
Research Study Groups:
This trial has the following groups:- Group 1: Intervention arm - Oral 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.
What is the target enrollment number for this clinical trial?
"That is accurate, the online clinical trials registry does show that the research team is currently looking for subjects. The listing went up on 8/6/2020 and was last updated on 8/12/2022. They are hoping to have 15 people participate at 1 location."
Answered by AI
Are Deutetrabenazine 6 MG's effects well-documented?
"Currently, there are five clinical trials underway that focus on Deutetrabenazine 6 MG. Out of these five research projects, two are in Phase 3. 70 different medical facilities across the United States are running these trials."
Answered by AI
Has this type of therapy been used before?
"Deutetrabenazine 6 MG has been studied since 2020, with the first trial being conducted that year and sponsored by Teva Branded Pharmaceutical Products R&D, Inc. After this initial study involving 185 people, Deutetrabenazine 6 MG received its Phase 3 drug approval. As of today, there are 5 live studies for Deutetrabenazine 6 MG across 21 cities and 11 countries."
Answered by AI
Who else is applying?
What state do they live in?
New York
What site did they apply to?
University of Pennsylvania
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
3+
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger