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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT00176553 |
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Date of registration:
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12/09/2005 |
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Primary sponsor: |
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Public title:
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A Pilot Study of Dextromethorphan for the Prevention and Treatment of Methotrexate Neurotoxicity
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Scientific title:
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A Pilot Study of Dextromethorphan for the Prevention and Treatment of Methotrexate Neurotoxicity |
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Date of first enrolment:
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March 2003 |
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Target sample size:
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20 |
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Recruitment status: |
Terminated |
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URL:
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http://clinicaltrials.gov/show/NCT00176553 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
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Countries of recruitment
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United States
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Contacts
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Name:
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Peter Cole, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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University of Medicine and Dentistry New Jersey |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Newly diagnosed acute lymphocytic leukemia (ALL), non-Hodgkin's lymphoma (NHL) or OS.
Patients will be separately stratified and randomized by disease.
- Patients with history of seizures are eligible but will be stratified separately.
Exclusion Criteria:
- Patients taking monoamine oxidase inhibitors (MAOIs) will be excluded from the study,
because of the risk of severe drug interactions.
- Pregnant or lactating women.
Age minimum:
2 Years
Age maximum:
21 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Neurotoxicity Syndromes
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Intervention(s)
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Drug: Dextromethorphan
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Primary Outcome(s)
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To determine whether dextromethorphan decreases the subacute toxicities associated with intravenous and intrathecal methotrexate
[Time Frame: 5 years]
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Secondary Outcome(s)
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To determine whether dextromethorphan can alleviate acute or subacute neurotoxicity when it does occur after intravenous or intrathecal methotrexate
[Time Frame: 5 years]
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Secondary ID(s)
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3708
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CINJ#110113
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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