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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
Must not have
Study subjects with a history of bipolar disorder or major depression, or the presence of active depression
Study subjects with a history of renal insufficiency
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 months
Awards & highlights
No Placebo-Only Group

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.
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.
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.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have a history of bipolar disorder, major depression, or currently have active depression.
Select...
I have a history of kidney problems.
Select...
I have been diagnosed with Parkinson's or a similar movement disorder.
Select...
My dystonia is confirmed to be dopa-responsive by genetic testing.
Select...
I have a history of significant liver disease.
Select...
My heart's electrical activity is within a safe range, and I have no history of irregular heartbeats.
Select...
I do not have any unstable medical conditions.
Select...
I have a neurological condition that might affect dystonia evaluations.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Proportion of Study Subjects Able to Titrate up to the Maximum Tolerated Dose
Secondary study objectives
Change in Dystonia Severity, as Determined by the Change in Median GDS Score
Change in Median Daytime Somnolence Score Among Subjects
Change in Median MMSE Score Among Subjects
+3 more

Side effects data

From 2024 Phase 1 & 2 trial • 15 Patients • NCT04173260
40%
Fatigue
20%
Somnolence
20%
COVID-19 infection
13%
Diarrhea
7%
Akathisia
7%
Headache
100%
80%
60%
40%
20%
0%
Study treatment Arm
Intervention Arm - Oral Deutetrabenazine

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Deutetrabenazine 6 MG
2021
Completed Phase 2
~20

Find a Location

Who is running the clinical trial?

University of PennsylvaniaLead Sponsor
2,084 Previous Clinical Trials
42,726,518 Total Patients Enrolled
Teva Branded Pharmaceutical Products R&D, Inc.Industry Sponsor
256 Previous Clinical Trials
3,486,449 Total Patients Enrolled

Media Library

Deutetrabenazine (Vesicular Monoamine Transporter 2 (VMAT2) Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT04173260 — Phase 1 & 2
Primary Dystonia Research Study Groups: Intervention arm - Oral Deutetrabenazine
Primary Dystonia Clinical Trial 2023: Deutetrabenazine Highlights & Side Effects. Trial Name: NCT04173260 — Phase 1 & 2
Deutetrabenazine (Vesicular Monoamine Transporter 2 (VMAT2) Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04173260 — Phase 1 & 2
~3 spots leftby Jan 2026
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