Recruiting soon

TD-AIDDDeutetrabenazine for Tardive Dyskinesia in Adults with Intellectual/Developmental Disabilities

0 criteria met from your profileSee at a glance how your profile meets each eligibility criteria.
What is being tested

Deutetrabenazine Oral Capsule

Drug
Who is being recruted

Tardive Dyskinesia+15

+ Caregiver Burden

+ Behavior

From 18 to 89 Years
+24 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 4
Interventional
Study Start: March 2026
See protocol details

Summary

Principal SponsorUniversity Hospitals Cleveland Medical Center
Study ContactMelissa Stasko, JD, MA
Last updated: February 6, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: March 1, 2026

Actual date on which the first participant was enrolled.

This clinical study focuses on treating a movement disorder called Tardive Dyskinesia (TD) in adults with intellectual and developmental disabilities (IDD) who also have psychiatric or behavioral disorders. TD is often a side effect of taking certain medications used to treat mental health conditions, and it can greatly affect a person's quality of life. People with IDD are particularly at risk for developing TD due to their frequent use of these medications. The study explores the use of a medication called deutetrabenazine, which has shown promise in reducing the symptoms of TD, offering hope for improved care for this vulnerable group. Participants in the study will receive deutetrabenazine to see how well it reduces the involuntary movements associated with TD. The study will carefully track changes in these movements using a tool called the Abnormal Involuntary Movement Scale (AIMS). Additionally, the study will assess whether the treatment helps with daily activities and quality of life, and reduces the burden on caregivers. By using several questionnaires, the study aims to provide a comprehensive understanding of the benefits of treating TD in people with IDD. This research could lead to better treatment strategies and improve the lives of those affected by this condition.

Official TitleIdentification, Assessment, and Treatment of Tardive Dyskinesia With Deutetrabenazine in Adults With Intellectual/Developmental Disabilities and Co-occurring Psychiatric and/or Behavioral Disorders
NCT06997198
Principal SponsorUniversity Hospitals Cleveland Medical Center
Study ContactMelissa Stasko, JD, MA
Last updated: February 6, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

25 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 89 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Tardive DyskinesiaCaregiver BurdenBehaviorMental DisordersBehavioral SymptomsCentral Nervous System DiseasesDevelopmental DisabilitiesDyskinesia, Drug-InducedIntellectual DisabilityMovement DisordersNervous System DiseasesNeurologic ManifestationsSigns and SymptomsStress, PsychologicalPathological Conditions, Signs and SymptomsNeurobehavioral ManifestationsDyskinesiasNeurodevelopmental Disorders

Criteria

9 inclusion criteria required to participate
Eligible to receive deutetrabenazine, according to current product labeling Stable doses of all psychotropic medications for minimum of three months before study inclusion
Able to comply with scheduled visits
Diagnosis of IDD (IQ < 70; social/adaptive dysfunction, onset < age 22) as per DSM-5
Willing to remain on stable doses of all psychotropics for 24 weeks of study. If female of childbearing age, practicing acceptable form of birth control throughout study duration.
Show More Criteria
15 exclusion criteria prevent from participating
Inability to take study medications
Unable to complete questionnaires
Previous treatment with a VMAT2 inhibitor (tetrabenazine, valbenazine, or deutetrabenazine).
Significant risk of suicide or dangerous aggression to others at time of or 3 months prior to study entry.
Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
This an open-label study in which all participants will have their Deutetrabenazine dose titrated from 12 mg to 24 mg per day, which will remain the Deutetrabenazine dose through end of study, unless interrupted by adverse events. Participants taking Deutetrabenazine who are concurrently taking strong CYP2D6 inhibitors (paroxetine, fluoxetine, bupropion, duloxetine) will continue their Deutetrabenazine dose at 24 mg per day through end of study.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

University Hospitals of Cleveland

Cleveland, United StatesOpen University Hospitals of Cleveland in Google Maps
Recruiting soonOne Study Center