Study Details

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

This trial is complete
The study has ended normally, and participants are no longer being examined or treated (that is, the last participant's last visit has occurred).

Clinicaltrials.gov ID

The unique identification code given to each clinical study upon registration at ClinicalTrials.gov.
NCT03557931

Astellas Study ID

The unique identification code given by the study sponsor.

4345-CL-0015

EudraCT ID

The unique identification code given to each clinical study upon registration at EudraCT (European Union Drug Regulating Authorities Clinical Trials Database).

N/A

Condition

Schizophrenia

Phase

These clinical trials are done to learn if an experimental treatment helps participants who have a specific condition or disease. Phase 2 trials usually include a larger group of participants than Phase 1 trials.

Phase 2

Age

18 years - 55 years

Sex

Female & Male

Product

N/A

Type

A type of clinical study in which participants are assigned to groups that receive one or more intervention/treatment (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.

Interventional

Trial Dates

Jul 2018 - Oct 2019

Masking

Triple (Participant, Investigator, Outcomes Assessor)

Enrollment number

233

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

Study summary

Study documents

Study Documents, including study results, are available after a study is completed or terminated, according to Astellas Transparency policy.

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Locations

California Neuropsychopharmacology Clinical Research Institute-LA, LLC

Pico Rivera, United States, 90660

Pacific Research Partners, LLC

Oakland, United States, 94607

InSite Clinical Research, LLC

DeSoto, United States, 75115

Cherry Street Services, Inc.

Grand Rapids, United States, 49503

Finger Lakes Clinical Research

Rochester, United States, 14618

New York State Psychiatric Institute

New York, United States, 10032

Pillar Clinical Research, LLC

Richardson, United States, 75080

Arch Clinical Trials, LLC

St. Louis, United States, 63118

CNS Research Science, Inc.

Cerritos, United States, 90703

Hassman Research Institute

Berlin, United States, 08009

Uptown Research Institute

Chicago, United States, 60640

Artemis Institute for Clinical Research

San Diego, United States, 92103

Community Clinical Research, Inc.

Austin, United States, 78754

Midwest Clinical Research Center

Dayton, United States, 45417

Sharp Mesa Vista Hospital

San Diego, United States, 92123

Alam Medical Research Inc.

Chicago, United States, 60612

Atlanta Center for Medical Research

Atlanta, United States, 30331

Manhattan Psychiatric Center’s 125th Street Clinic

New York, United States, 10035

Michigan Clinical Research Institute PC

Ann Arbor, United States, 48105

Woodland Research Northwest, LLC

Rogers, United States, 72758

SPRI Clinical Trials, LLC

Brooklyn, United States, 11235

CNS Research Science, Inc.

Jamaica, United States, 11432

Synergy East

Lemon Grove, United States, 91945

Albuquerque Neuroscience Inc.

Albuquerque, United States, 87109

Collaborative Neuroscience Network, LLC

Torrance, United States, 90502

Collaborative Neuroscience Network, LLC

Garden Grove, United States, 92845

California Neuropsychopharmacology Clinical Research Institute, LLC (CNRI-San Diego)

San Diego, United States, 92102

Radiant Research, Inc.

Atlanta, United States, 30328

Pillar Clinical Research, LLC

Garland, United States, 75042