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

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.

Conditions

• Schizophrenia

Interventions

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

Sponsors & Collaborators

• Astellas Pharma Global Development, Inc.

  lead INDUSTRY

Principal Investigators

• Executive Medical Director · Astellas Pharma Global Development

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

55 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2018-07-13

Primary Completion

2019-10-21

Completion

2019-10-21

FDA Drug

Yes

Countries

• United States

Study Locations