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A Study to Assess the Safety and Efficacy of ASP4345 as Add-on Treatment for Cognitive Impairment in Subjects With Schizophrenia on Stable Doses of Antipsychotic Medication

NCT03557931 ↗

Phase 2 Completed 233 enrolled Astellas Pharma Global Development, Inc.
RandomizedParallel-groupTriple-blindTreatment

Summary

The purpose of this study was to evaluate the efficacy of ASP4345 on cognitive impairment compared to placebo using change from baseline in MATRICS Consensus Cognitive Battery (MCCB) neurocognitive composite score (excluding social cognition domain). The primary estimand used a Hypothetical Strategy and compared participants as though the participant had continued on the assigned treatment and to evaluate the safety and tolerability of ASP4345 compared to placebo. This study also evaluated the effects of ASP4345 compared to placebo on functional capacity using the University of California San Diego Performance-based Skills Assessment-2 Extended Range (UPSA-2-ER) total score and evaluated the pharmacokinetic profile of ASP4345.

Timeline

Start
2018-07-13
Primary completion
2019-10-21
Completion
2019-10-21

Outcome

Missed primary endpoint

registry analysis (superiority test); Placebo vs ASP4345 50 mg; p = 0.858; LS Mean Difference 0.18 (90% CI -1.51 to 1.88); MMRM Method NCT03557931 ↗

registry analysis (superiority test); Placebo vs ASP4345 150 mg; LS Mean Difference -0.28 (90% CI -1.93 to 1.36); 0.775 NCT03557931 ↗

Publications

Drugs

EvaluationDrugModalityDoseRoute
Subject ASP4345 Small molecule 50 mg Oral
Subject ASP4345 Small molecule 150 mg Oral
Background Aripiprazole Other / unclassified — Oral
Background Brexpiprazole Small molecule — Oral
Background Lurasidone Small molecule — Oral
Background Olanzapine Small molecule — Oral
Background Paliperidone Unknown — Oral
Background Quetiapine Small molecule — Oral
Background Risperidone Other / unclassified — Oral
Background Ziprasidone Small molecule — Oral

Indications

schizophrenia