Clinical Trial: A Pilot Study of Dextromethorphan for the Prevention and Treatment of Methotrexate Neurotoxicity

Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional

Official Title: A Pilot Study of Dextromethorphan for the Prevention and Treatment of Methotrexate Neurotoxicity

Brief Summary: The purposes of this study are to find out whether dextromethorphan can prevent the short or long-term neurologic side effects of methotrexate, and whether dextromethorphan can improve symptoms of short-term neurologic side effects if they do occur.

Detailed Summary: We believe that we are beginning to understand the biological cause of the neurotoxicity that happens after treatment with methotrexate. Dextromethorphan, an ingredient in common cough medicines, may be able to prevent and/or treat this neurotoxicity. We have given dextromethorphan to a small group of patients who developed severe neurologic side effects after methotrexate. All had a complete recovery within one day.
Sponsor: University of Medicine and Dentistry of New Jersey

Current Primary Outcome: To determine whether dextromethorphan decreases the subacute toxicities associated with intravenous and intrathecal methotrexate [ Time Frame: 5 years ]

Original Primary Outcome: To determine whether dextromethorphan decreases the subacute toxicities associated with intravenous and intrathecal methotrexate.

Current Secondary Outcome: To determine whether dextromethorphan can alleviate acute or subacute neurotoxicity when it does occur after intravenous or intrathecal methotrexate [ Time Frame: 5 years ]

Original Secondary Outcome: To determine whether dextromethorphan can alleviate acute or subacute neurotoxicity when it does occur after intravenous or intrathecal methotrexate.

Information By: Rutgers, The State University of New Jersey

Dates:
Date Received: September 12, 2005
Date Started: March 2003
Date Completion:
Last Updated: December 10, 2009
Last Verified: December 2009