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Vesicular Monoamine Transporter 2 (VMAT2) Inhibitor

Valbenazine for Tardive Dyskinesia

Phase 1
Recruiting
Led By John De Figueiredo, MD
Research Sponsored by Yale University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age: 26-84
Diagnosis of dopamine receptor-blocker induced tardive dyskinesia according to the DSM-5 criteria: "involuntary athetoid or choreiform movements lasting at least a few weeks, developing in association with the use of a neuroleptic medication for at least a few months, and persisting beyond 4-8 weeks"
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, week 2, week 4, and week 6
Awards & highlights
No Placebo-Only Group

Summary

This trial aims to see if treating tardive dyskinesia with Valbenazine can help reduce demoralization.

Who is the study for?
This trial is for individuals aged 26-84 who have been diagnosed with tardive dyskinesia, a condition causing involuntary movements, as a result of taking neuroleptic medications. Both males and females are eligible if they meet the DSM-5 criteria for this condition.
What is being tested?
The study is testing whether Valbenazine can help reduce feelings of demoralization in patients with tardive dyskinesia by treating their symptoms. It's a preliminary step to see if it's worth doing larger studies on this potential treatment.
What are the potential side effects?
While specific side effects aren't listed here, Valbenazine may cause sleepiness, balance problems, dry mouth, and sometimes restlessness or an urge to move (akathisia).

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am between 26 and 84 years old.
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I have involuntary movements due to medication for mental health.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, week 2, week 4, and week 6
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, week 2, week 4, and week 6 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change in demoralization Scale
Secondary study objectives
Change in subjective incompetence scale (SIS) score

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: ValbenazineExperimental Treatment1 Intervention
All participants will be treated with Valbenazine for 7 weeks.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Valbenazine
2018
Completed Phase 4
~880

Find a Location

Who is running the clinical trial?

Yale UniversityLead Sponsor
1,924 Previous Clinical Trials
3,031,643 Total Patients Enrolled
1 Trials studying Tardive Dyskinesia
50 Patients Enrolled for Tardive Dyskinesia
Neurocrine BiosciencesIndustry Sponsor
75 Previous Clinical Trials
6,706 Total Patients Enrolled
12 Trials studying Tardive Dyskinesia
1,174 Patients Enrolled for Tardive Dyskinesia
John De Figueiredo, MDPrincipal InvestigatorClinical Professor of Psychiatry
~7 spots leftby Jan 2025
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