NCT03557931

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

A Phase 2a, Randomized, Double-Blind, Placebo-Controlled, Parallel-group 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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 233 (actual)
• Sponsor: Astellas Pharma Global Development, Inc. · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Participants received oral doses of ASP4345 or matching placebo QD (once daily) for 12 weeks. All participants were administered the first dose of blinded study drug at the site following randomization and provided with web-based applications that provided supplemental cognitive training and recorded treatment compliance. Participants returned to the clinic weekly for safety, efficacy, and/or pharmacokinetic procedures. Participants continued the participant's antipsychotic treatment for the entire study and were followed for 14 days after the participant's last dose of study drug.

Conditions

• Schizophrenia

Interventions

Type	Name	Description
DRUG	ASP4345	oral administration
DRUG	placebo	oral administration
DRUG	risperidone	oral or depot administration
DRUG	quetiapine	oral administration
DRUG	olanzapine	Oral or depot administration
DRUG	ziprasidone	Oral or depot administration
DRUG	aripiprazole	Oral or depot administration
DRUG	brexpiprazole	Oral administration
DRUG	paliperidone	Oral or depot administration
DRUG	lurasidone	Oral administration

Timeline

• Start date: 2018-07-13
• Primary completion: 2019-10-21
• Completion: 2019-10-21
• First posted: 2018-06-15
• Last updated: 2024-11-12
• Results posted: 2020-10-27

Locations

27 sites across 1 country: United States

Regulatory

• FDA-regulated drug study