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

NCT00176553 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2009-12-11

No results posted yet for this study

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.

Conditions

  • Neurotoxicity Syndromes

Interventions

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.

Sponsors & Collaborators

  • University of Medicine and Dentistry of New Jersey

    lead OTHER

Principal Investigators

  • Peter Cole, MD · Rutgers, The State University of New Jersey

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
SINGLE_GROUP

Eligibility

Min Age
2 Years
Max Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2003-03-31
Primary Completion
2007-05-31
Completion
2007-05-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00176553 on ClinicalTrials.gov