Status:
NOT_YET_RECRUITING
Deutetrabenazine Treatment for Tardive Dyskinesia in Intellectual/Developmental Disabilities
Lead Sponsor:
University Hospitals Cleveland Medical Center
Collaborating Sponsors:
Teva Pharmaceuticals USA
Conditions:
Tardive Dyskinesia
Intellectual Disability
Eligibility:
All Genders
18-89 years
Phase:
PHASE4
Brief 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 ...
Detailed Description
Tardive dyskinesia (TD) is recognized as a common and often debilitating movement disorder, associated with treatment of a variety of illnesses with dopamine receptor-blocking medications (also common...
Eligibility Criteria
Inclusion
- Participant
- 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
- Able to understand and answer questionnaires
- Able to comply with scheduled visits
- Ability to be primary Caregiver for 24 weeks of study
- Participant
Exclusion
- 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
Key Trial Info
Start Date :
December 15 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2027
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT06997198
Start Date
December 15 2025
End Date
October 1 2027
Last Update
November 24 2025
Active Locations (1)
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1
University Hospitals of Cleveland
Cleveland, Ohio, United States, 44106