This is a Phase 4, randomized, double-blind, placebo-controlled study to evaluate the potential for clinical dependence and withdrawal symptoms associated with valbenazine.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
89
vesicular monoamine transporter 2 (VMAT2) inhibitor
non-active dosage form
Neurocrine Clinical Site
Anaheim, California, United States
Neurocrine Clinical Site
Glendale, California, United States
Participants With Withdrawal-Emergent Adverse Events
A withdrawal-emergent adverse event is an adverse event that begins during the Withdrawal Period.
Time frame: 3 weeks
Participants Who Experience Worsening of Symptoms as Measured by the Physician Withdrawal Checklist-20 (PWC-20)
The PWC-20 is a validated 20-item physician-rated survey that assesses the severity of potential symptoms of withdrawal. Items are rated on a scale from 0 to 3, with total scores ranging from 0 to 60. Worsening of symptoms is defined by 5 new symptoms of moderate or severe degree or a worsening of symptoms by 2 points on the PWC-20 scale during Weeks 5 to 7 compared with Week 4. Note: a 2-point worsening from 0 (none) at Week 4 to 2 (moderate) post-Week 4 is counted as a worsening of symptoms.
Time frame: 3 weeks
Absolute Worst Total Score as Measured by the Physician Withdrawal Checklist-20 (PWC-20)
The PWC-20 is a validated 20-item physician-rated survey that assesses the severity of potential symptoms of withdrawal. Items are rated on a scale from 0 to 3, with total scores ranging from 0 to 60. Larger values indicate more severe symptoms. Rickels et al (J Clin Psychopharmacol 2008) cites PWC-20 mean scores associated with withdrawal in the range of 15 to 24.
Time frame: 3 weeks
Severity of Withdrawal Symptoms as Measured by the Change From Withdrawal Baseline (Week 4) to Week 7 in the Modified Cocaine Selective Severity Assessment (mCSSA)
The mCSSA is an 18-item survey based on symptoms commonly associated with early cocaine abstinence, including depression, fatigue, anhedonia, anxiety, irritability, sleep disturbance, and inability to concentrate. Items are rated on scales of 0 to 7 or 0 to 8, with separate scale descriptions for each item. Larger values indicate more severe symptoms. The scale has been modified to be specific to study drug (valbenazine or placebo) instead of cocaine.
Time frame: 7 weeks
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Neurocrine Clinical Site
Norwalk, California, United States
Neurocrine Clinical Site
Oceanside, California, United States
Neurocrine Clinical Site
San Bernardino, California, United States
Neurocrine Clinical Site
Hialeah, Florida, United States
Neurocrine Clinical Site
Hialeah, Florida, United States
Neurocrine Clinical Site
Hialeah, Florida, United States
Neurocrine Clinical Site
Honolulu, Hawaii, United States
Neurocrine Clinical Site
Fort Wayne, Indiana, United States
...and 7 more locations
Overall Improvement From Baseline of TD Symptoms as Measured by the Clinical Global Impression-Tardive Dyskinesia-Improvement (CGI-TD-I) Score
The CGI-TD-I scale is a 7-point scale (range; 1=very much improved to 7=very much worse) used to assess overall improvement in TD symptoms since the initiation of study drug dosing.
Time frame: Baseline, Week 4, Week 7
Change in Severity of TD Symptoms as Measured by Change From Baseline in the Clinical Global Impression-Tardive Dyskinesia-Severity (CGI-TD-S) Scale
The CGI-TD-S scale is a 7-point scale (range; 1=normal, not at all ill to 7=among the most extremely ill patient) used to assess the overall global severity of TD.
Time frame: Baseline, Week 4, Week 7