This Phase 2 study was designed to evaluate the efficacy and safety of SNC-102 in subjects with drug-induced Tardive Dyskinesia (TD). To ensure an adequate evaluation of SNC-102, a randomized, double-blind, parallel-group, placebo-controlled trial was designed. Two dosing levels of SNC-102 are employed to evaluate the proposed dosing range. A target enrollment of 90 subjects with drug-induced TD will provide sufficient data to assess the efficacy and safety profiles of SNC-102 in the target population.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
UCLA - Greater Los Angeles
Los Angeles, California, United States
Efficacy as measured by changes from baseline in summary scores on the Abnormal Involuntary Movement Scale (AIMS)
Determine the efficacy relative to placebo of SNC-102 in subjects with drug-induced tardive dyskinesia (TD), as assessed by changes from baseline to four weeks in summary scores on the Abnormal Involuntary Movement Scale (AIMS)
Time frame: 4 weeks
Compare the effectiveness of low dose and high dose of SNC-102
Compare the effectiveness of low dose and high dose, as assessed by changes from baseline to four weeks in summary scores on the Abnormal Involuntary Movement Scale (AIMS)
Time frame: 4 weeks
Assess safety and tolerability of SNC-102 in the tardive dyskinesia population
Nature and frequency of adverse events; changes from baseline in tests of psychiatric symptoms and cognitive function.
Time frame: 4 weeks
Assess the pharmacokinetic (PK) profile in TD subjects
Measure and analyze the serum concentration of acamprosate.
Time frame: 4 weeks
Determine the relationship between the PK profile and clinical effects of SNC-102
Describe the correlation between change in AIMS score and serum levels of acamprosate.
Time frame: 4 weeks
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