RecruitingPhase 4NCT06997198

Deutetrabenazine Treatment for Tardive Dyskinesia in Intellectual/Developmental Disabilities

Identification, Assessment, and Treatment of Tardive Dyskinesia With Deutetrabenazine in Adults With Intellectual/Developmental Disabilities and Co-occurring Psychiatric and/or Behavioral Disorders

Sponsor

University Hospitals Cleveland Medical Center

Enrollment

25 participants

Start Date

Jun 22, 2026

Study Type

INTERVENTIONAL

Conditions

Developmental Disabilities Intellectual Disability Tardive Dyskinesia

Summary

The primary goal of this study is to investigate the efficacy of deutetrabenazine treatment of TD in this previously untreated patient population. Compare movement disorder deutetrabenazine treatment response in persons with IDD to response seen in patients without IDD treated with deutetrabenazine in other treatment settings (per literature review). Compare global deutetrabenazine treatment response with validated instruments. In addition, we plan to: * Assess the safety of deutetrabenazine in the treatment of TD in persons with IDD. * Assess change in Activities of Daily Living (ADLs) in persons with IDD and TD treated with deutetrabenazine, utilizing a validated ADL instrument. * Assess change in Quality of Life (QOL) in persons with IDD and TD treated with deutetrabenazine, utilizing a validated QOL instrument. * Assess caregiver burden with a validated caregiver burden instrument. In this study, 25 participants with IDD and TD will undergo Deutetrabenazine treatment for 24 weeks. The participants will be seen for a total of 5 visits: at baseline, and at follow up visits at 3 weeks, 6 weeks, 12 weeks, and 24 weeks. This study does not include a comparison group. Therefore, researchers will compare the response of the study participants to deutetrabenazine treatment with those from a previous reported work that resulted in the FDA approval of this medication. This will be an open-label, Phase 4 study.

Eligibility

Min Age: 18 YearsMax Age: 89 Years

Inclusion Criteria9

Diagnosis of IDD (IQ < 70; social/adaptive dysfunction, onset < age 22) as per DSM-5
Clinical diagnosis of Tardive Dyskinesia (TD) per DSM-5 for at least 3 months before study inclusion (presence of movement disorder for at least 3 months, in absence of previous formal diagnosis of TD).
Eligible to receive deutetrabenazine, according to current product labeling Stable doses of all psychotropic medications for minimum of three months before study inclusion
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.
Subject able to comply with scheduled visits and assessments
Consent of subject, or legally authorized representative to study protocol.
Able to understand and answer questionnaires
Able to comply with scheduled visits
Ability to be primary Caregiver for 24 weeks of study

Exclusion Criteria15

Previous treatment with a VMAT2 inhibitor (tetrabenazine, valbenazine, or deutetrabenazine).
Treatment with any investigational drug in the 30 days prior to study entry.
Currently taking a strong CYP2D6 inhibitor such as fluoxetine, paroxetine, quinidine, bupropion. Current treatment with strong anticholinergic agents, monoamine oxidase inhibitors, metoclopramide, dopamine agonists, L-DOPA, or stimulants within past 30 days, or botulinum toxin within the past 3 months.
Any unstable medical condition in the 60 days prior to study entry.
Pregnant or breast-feeding
Current or recent hepatic impairment
History of neuroleptic malignant syndrome
History of long QTc on electrocardiogram, bundle branch block (BBB), atrioventricular block, serious cardiac arrhythmia, or heart failure.
QTc on EKG > 450 msec (Fredericia formula) on EKG within 3 months prior to study entry.
History of substance abuse or dependence in the 3 months prior to study entry.
Significant risk of suicide or dangerous aggression to others at time of or 3 months prior to study entry.
Inability to take study medications
Unable to complete questionnaires
Unable to comply with scheduled visits
Will not be a primary Caregiver for the 24 weeks of the study

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Interventions

DRUGDeutetrabenazine Oral Capsule

Open-label twenty-four-week treatment with Deutetrabenazine oral tablets (up to 24 mg/day) to test the safety and effectiveness of this medication in ameliorating the signs of tardive dyskinesia in persons with intellectual disability.