Study to evaluate the safety and efficacy of luvadaxistat compared with placebo on improving cognitive performance in participants with schizophrenia.
A Phase 2, randomized, double-blind, parallel, placebo-controlled study with a 6- or 12-month open-label extension. The study is designed to evaluate the efficacy, safety and tolerability, and pharmacokinetics (PK) of treatment with luvadaxistat when administered orally once daily as an adjunctive treatment on improving symptoms of cognitive impairment associated with schizophrenia (CIAS).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
216
Oral tablets
Oral tablets
Change From Baseline on the Brief Assessment of Cognition in Schizophrenia (BAC) Composite Score
Time frame: Baseline, Day 98
Change From Baseline on the Schizophrenia Cognition Rating Scale (SCoRS) Interviewer Score
Time frame: Baseline, Day 98
Change From Baseline on the Virtual Reality Functional Capacity Assessment Tool (VRFCAT)
Time frame: Baseline, Day 98
Change From Baseline on the Clinical Global Impression-Severity Scale (CGI-S) Score
Time frame: Baseline, Day 98
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Bentonville, Arkansas, United States
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Anaheim, California, United States
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Glendale, California, United States
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Oceanside, California, United States
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Pico Rivera, California, United States
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San Diego, California, United States
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