Deutetrabenazine Treatment for Tardive Dyskinesia in Intellectual/Developmental Disabilities

Launched by UNIVERSITY HOSPITALS CLEVELAND MEDICAL CENTER · May 21, 2025

Keywords

ClinConnect Summary

This clinical trial is studying the effects of a medication called deutetrabenazine in treating tardive dyskinesia (TD) in individuals with intellectual and developmental disabilities (IDD). TD is a movement disorder that can cause involuntary movements, and this study aims to see how well deutetrabenazine works for those who haven’t received treatment before. The researchers will also look at how safe the medication is, how it affects daily life activities, quality of life, and the burden on caregivers.

To be eligible for this study, participants must have a diagnosis of IDD and a clinical diagnosis of TD for at least three months. They should also be able to follow medication guidelines and attend scheduled visits. The trial will involve 25 participants who will receive treatment for 24 weeks and attend five visits to check on their progress. It's important to note that this study does not have a comparison group, meaning that results will be compared to previous studies rather than a control group. This is an opportunity to help researchers understand how to better support individuals with IDD and TD.

Gender

ALL

Eligibility criteria

• Participant Inclusion Criteria:
• • 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.
• Caregiver Inclusion Criteria:
• • Able to understand and answer questionnaires
• • Able to comply with scheduled visits
• • Ability to be primary Caregiver for 24 weeks of study
• Participant Exclusion Criteria:
• • 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
• Caregiver Exclusion Criteria:
• • Unable to complete questionnaires
• • Unable to comply with scheduled visits
• • Will not be a primary Caregiver for the 24 weeks of the study