A Safety and Tolerability Study of 42037788 (Referred to as CNTO 0007) Compared With Placebo in Patients Who Have Experienced Ischemic Cerebral Infarction (Also Known as Stroke)

• Status: Completed
• Trial end date: 2013-07-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate the safety and tolerability of 42037788 (CNTO 0007) in patients who have suffered a stroke. The study is not designed to establish efficacy, although preliminary explorations will be conducted.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Janssen Research & Development, LLC

Criteria

Inclusion Criteria:

• Adult patients who have suffered an ischemic stroke, as defined by the protocol (If a woman, must be postmenopausal, defined as having no menses for the 18 months before study start. Premenopausal, surgically-sterilized women must have a negative serum beta human chorionic gonadotropin pregnancy test at screening before CNTO 0007 or placebo administration)

• Patients must be able to remain as inpatients for at least 3 days post-infusion for intensive safety monitoring

• Patients must receive standard post-stroke care before the infusion begins and after treatment with experimental product, including but not limited to appropriate secondary prevention measure such as blood pressure and cholesterol control and antiplatelet agents, unless contraindicated

• Patient must have no clinical evidence of worsening stroke in the last 24 hours prior to the start of the infusion of study treatment

• Patients must have general medical condition consistent with expected survival for at least 1 year.

Exclusion Criteria:

• Presence or history of any clinically significant disease, medical condition, or treatment intervention as determined by the Investigator

• Need for supplementary oxygen for cardiorespiratory reasons or respirator dependency. If supplementary oxygen is not needed for cardiopulmonary reasons but given on a routine basis, it is not exclusionary

• Presence or history of alcohol or drug abuse as defined by the 4th edition of the Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) within 1 year before the screening phase.