Status:
WITHDRAWN
Valbenazine Treatment of Tardive Dyskinesia in Adults With Intellectual/Developmental Disabilities
Lead Sponsor:
Stephen Ruedrich
Collaborating Sponsors:
Neurocrine Biosciences
Conditions:
Tardive Dyskinesia
Intellectual Disability
Eligibility:
All Genders
18-70 years
Phase:
PHASE4
Brief Summary
The goal of this open-label clinical trial is to test the safety and efficacy of valbenazine treatment in patients with Intellectual/Developmental Disability (IDD) who have a diagnosis of Tardive dysk...
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
- 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 valbenazine 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 for birth control throughout study duration.
- Subject able to comply with scheduled visits and assessments.
- Consent of subject, or legally authorized representative to study protocol.
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 CYP3A4 inducer such as carbamazepine, phenobarbital, diphenylhydantoin, or primidone.
- Any unstable medical condition in the 60 days prior to study entry.
- Pregnant or breast-feeding.
- Inability to take study medication.
- 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.
Key Trial Info
Start Date :
January 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2027
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT06107829
Start Date
January 1 2025
End Date
February 1 2027
Last Update
October 24 2024
Active Locations (1)
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1
University Hospitals of Cleveland
Cleveland, Ohio, United States, 44106