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Vesicular Monoamine Transporter 2 (VMAT2) Inhibitor

Valbenazine for Tardive Dyskinesia (TD-AIDD Trial)

Phase 4
Waitlist Available
Led By Stephen Ruedrich, MD
Research Sponsored by Stephen Ruedrich
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Eligible to receive valbenazine according to current product labeling
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline and 24 weeks from start of treatment
Awards & highlights

TD-AIDD Trial Summary

This trial will test the safety and effectiveness of valbenazine in adults with IDD and TD, comparing the results to a previous study that resulted in FDA approval.

Who is the study for?
This trial is for adults with Intellectual/Developmental Disabilities (IDD) who have Tardive Dyskinesia (TD). Participants must be able to visit the clinic, take valbenazine safely according to its label, and have stable doses of psychotropic meds for three months. Women of childbearing age should use birth control during the study.Check my eligibility
What is being tested?
The trial tests if valbenazine can help improve movement disorders in adults with IDD and TD over a period of 24 weeks. It will also look at safety, quality of life improvements, daily living activities, and caregiver burden without comparing it to another group.See study design
What are the potential side effects?
While not specified here, common side effects from similar studies may include sleepiness, balance problems when standing up quickly, dry mouth or blurry vision. Each person's experience with side effects could vary.

TD-AIDD Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am approved to take valbenazine as per its usage guidelines.

TD-AIDD Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline and 24 weeks from start of treatment
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline and 24 weeks from start of treatment for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in AIMS total scores of items 1-7
Secondary outcome measures
CGI-C
CaGI-C
Change in ABC-I score
+3 more
Other outcome measures
Assessment of electrocardiogram (EKG)-derived QT/QTc intervals
Change Simpson-Angus Scale for EPS
Change in Barnes Akathisia Scale

TD-AIDD Trial Design

1Treatment groups
Experimental Treatment
Group I: ValbenazineExperimental Treatment1 Intervention
This an open-label study in which all participants will have their valbenazine dose titrated from 40 mg to 80 mg per day, which will remain the valbenazine dose through end of study, unless interrupted by adverse events. Participants taking valbenazine who are concurrently taking strong CYP2D6 inhibitors (paroxetine, fluoxetine, bupropion, duloxetine) will continue their valbenazine dose at 40 mg per day through end of study. Participants taking valbenazine who are concurrently taking strong CYP3A4 inhibitors (ketoconazole, fluconazole, cimetidine, verapamil) will continue their valbenazine dose at 40 mg per day through end of study.

Find a Location

Who is running the clinical trial?

Neurocrine BiosciencesIndustry Sponsor
75 Previous Clinical Trials
6,726 Total Patients Enrolled
12 Trials studying Tardive Dyskinesia
1,189 Patients Enrolled for Tardive Dyskinesia
Stephen RuedrichLead Sponsor
Stephen Ruedrich, MDPrincipal InvestigatorUniversity Hospitals Cleveland Medical Center

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are the eligibility criteria for participants in this medical experiment?

"Patients that are between 18 and 70 years old, who have been diagnosed with intellectual disability can apply to join this clinical trial. Moreover, 25 individuals in total will be chosen for the study."

Answered by AI

Has Valbenazine been validated by the Food and Drug Administration?

"With its Phase 4 status, Valbenazine was deemed safe and thus rated 3 on our team's safety scale."

Answered by AI

Does this investigation involve individuals of more advanced age?

"The age limit for this study is 18 to 70 years old. There are also 63 trials specifically targeting minor patients and 57 that only admit those above 65."

Answered by AI

Are there still vacancies for participants in this research?

"As indicated on clinicaltrials.gov, this medical investigation is not presently welcoming individuals to join the study. This research began recruitment on March 1st 2024 and was last updated October 25th 2023. However, there are 103 other trials actively recruiting subjects at present."

Answered by AI

Who else is applying?

What site did they apply to?
University Hospitals of Cleveland
What portion of applicants met pre-screening criteria?
Did not meet criteria
Recent research and studies
clinicaltrials.govStudy
Valbenazine Treatment of Tardive Dyskinesia in Adults With Intellectual/Developmental Disabilities
Stephen Ruedrich 2024. "Valbenazine Treatment of Tardive Dyskinesia in Adults With Intellectual/Developmental Disabilities". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06107829.
All > Tardive Dyskinesia
~17 spots leftby Aug 2026
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