NCT00176553

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

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: University of Medicine and Dentistry of New Jersey · Academic / Other
• Sex: All
• Age: 2 Years – 21 Years
• Healthy volunteers: Not accepted

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 description

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.

Conditions

• Neurotoxicity Syndromes

Interventions

Type	Name	Description
DRUG	Dextromethorphan	Patients will receive an inert carrier with or without dextromethorphan. The study drug will be administered at 1.5 mg/kg/dose on a BID schedule. The first dose to be given prior to each scheduled intravenous and/or intrathecal administration of methotrexate and continued for a total of seven days.

Timeline

• Start date: 2003-03-01
• Primary completion: 2007-05-01
• Completion: 2007-05-01
• First posted: 2005-09-15
• Last updated: 2009-12-11

Locations

1 site across 1 country: United States