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10. Title: A multi-site, open label study to evaluate 250mg oral Neotrofin BID in patients with subacute complete spinal cord injury over 12 weeks.

Purpose:The purpose of this study is to evaluate the safety and efficacy of the experimental medication Neotrofin in patients with subacute complete spinal cord injury.

Principal Investigator: Anthony S. Burns. MD

Background: It has been speculated that the drug Neotrofin may be of benefit to patients with spinal cord injuries because previous studies have shown the drug has some neuroprotective effects. This may be because Neotrofin stimulated certain neurotransmitters and/or it inhibits others.

The purpose of this study is to evaluate the safety and efficacy of the experimental medication Neotrofin in patients with subacute complete spinal cord injury. Individuals who participate in this study will be screened, given a thorough medical exam, asked to sign a consent. They will be followed by physicians and staff of the RSCICDV. Participation will require several return visits to the Center for followup and testing.

Status: Complete