Phase
Condition
Tardive Dyskinesia
Dyskinesias
Treatment
Valbenazine
Clinical Study ID
Ages 26-84 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Age: 26-84
Sex: Both males and females will be included
Diagnosis of dopamine receptor-blocker induced tardive dyskinesia according to theDSM-5 criteria: "involuntary athetoid or choreiform movements lasting at least a fewweeks, developing in association with the use of a neuroleptic medication for atleast a few months, and persisting beyond 4-8 weeks"
Exclusion
Exclusion Criteria:
The following classes of patients will be excluded:
Patients with unstable psychiatric status defined as having a total score on BPRS of 50 or higher
Patients who have suicidal or homicidal ideation, intent, or plan or viewed ashaving a significant risk of suicidal or violent behavior;
Patients with cognitive impairment as defined by a score of 24 or less on the MMSE
Patients with current diagnosis of alcohol or substance use disorder made accordingto DSM-5 criteria
Patients with clinically significant unstable medical condition defined as follows:a comorbid abnormal movement disorder more prominent than tardive dyskinesia (e.g.,parkinsonism, akathisia, truncal dystonia), a score of greater than 2 on two or moreitems of the Simpson-Angus Scale, or a history of neuroleptic malignant syndrome.
Patients previously treated with Valbenazine or any other medication specificallyindicated for tardive dyskinesia
Patients currently taking strong CYP3A4 inducers, dopamine agonists, MAO inhibitors,stimulants, and/or VMAT2 inhibitors
Patients with congenital long QT syndrome or arrhythmias associated with prolongedQT interval
Patients with risk factors for prolonged QT such as electrolyte abnormalities (hypokalemia, hypocalcemia, hypomagnesemia), anorexia nervosa, diuretic use, certainheart conditions, and other medical conditions
Patients tested positive for Coronavirus Covid-19
Patients with impaired decision-making capacity
Institutionalized individuals
Prisoners
Study Design
Connect with a study center
Yale Church Street Research Unit.
New Haven, Connecticut 06520
United StatesActive - Recruiting
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