Induction Therapy With a Single High Dose Bolus of Intravenous Methotrexate With Leucovorin Rescue, Prior to Initiation of AVONEX® Treatment, in Patients Presenting With a First Acute Demyelinating Event.

April 10, 2018 updated by: Vernon D. Rowe III, MD, MidAmerica Neuroscience Research Foundation at Rowe Neurology Institute

An Open Label Pilot Study of Induction Therapy With a Single High Dose Bolus of Intravenous Methotrexate With Leucovorin Rescue, Prior to Initiation of AVONEX® Treatment, in Patients Presenting With a First Acute Demyelinating Event: Comparison With CHAMPS Results.

The participant will receive weekly intramuscular treatment with AVONEX® (interferon beta 1-a) and a one-time high dose intravenous methotrexate with Leucovorin rescue, along with the standard solumedrol treatment before beginning AVONEX® treatment.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Detailed Description

The participant will receive weekly intramuscular treatment with AVONEX® (interferon beta 1-a) and a one-time high dose intravenous methotrexate with Leucovorin rescue, along with the standard solumedrol treatment before beginning AVONEX® treatment.

At study entrance, baseline lab work (complete blood count, platelet count, routine electrolytes, blood urea nitrogen, creatinine, liver function tests, 24 hour urine collection for creatinine clearance, urine pregnancy test, urinalysis and urine culture and sensitivity if needed), and an electrocardiogram (measurement of heart activity) will be done. A complete medical history, neurological and opthamological examination will be performed, including measurements of vital signs (heart rate and blood pressure), as well as magnetic resonance imaging (MRI), EDSS, and Visual Evoked Response test (VER's) to document status of disease. A Multiple Sclerosis Functional Composite Score (MSFC) consists of the Timed 25 Foot Walk, Nine Hole Peg Test (9HPT), and Paced Auditory Serial Addition Test 3 (PASAT3) will be performed at screen as well. At months 6, 12, 18, 24, 30 and 36 the tests and evaluations will include MRI, MSFC, VER's and blood tests of immune cells. Other safety evaluations (previously mentioned blood and urine tests) will be conducted according to the date of treatment. These tests include a laboratory test (methotrexate level) two days following treatment, as well as routine lab tests 2 weeks following the methotrexate treatment. This treatment would be under the supervision of Dr. Rowe.

The patients will continue their AVONEX® intramuscular injections of 30 micrograms (administered by patient or caregiver) on a weekly basis. The methylprednisolone treatment and methotrexate infusion will be performed in our outpatient infusion center. The patient will be required to complete a patient diary during the course of the trial, participate in and keep all scheduled appointments, and to inform the research staff and physician of any change in concomitant medications or adverse events that they may experience.

Study Type

Interventional

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Missouri
      • Kansas City, Missouri, United States, 64108
        • MidAmerica Neuroscience Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

To be eligible for entry into this study, candidates must meet the following eligibility criteria at the time of enrollment, which are the same as in the CHAMPS study [1]:

  • Between the ages of 18 and 50 years, inclusive.
  • As in the CHAMPS study [1] patients must have had a first isolated, well-defined neurologic event consistent with demyelination and involving the optic nerve (unilateral optic neuritis), spinal cord (incomplete transverse myelitis), or brain stem or cerebellum (brain stem or cerebella syndrome). They must also have two or more clinically silent lesions of the brain that were at least 3 mm in diameter on MRI scans and were characteristic of MS (at least one lesion must be periventricular or ovoid).
  • The onset of the visual or neurological symptoms must have occurred no more than twelve days before the MTX treatment, so that the methylprednisolone treatment is begun no more than fourteen days after the onset of symptoms, as in CHAMPS.
  • Patients must give written informed consent prior to any testing under this protocol, including screening tests and evaluations that are not considered part of the subject's routine care.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

MidAmerica Neuroscience Research Foundation at Rowe Neurology Institute

Collaborators

Consultants in Neurology

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2002

Primary Completion (Actual)

December 1, 2002

Study Completion (Actual)

December 1, 2002

Study Registration Dates

First Submitted

May 15, 2002

First Submitted That Met QC Criteria

May 16, 2002

First Posted (Estimate)

May 17, 2002

Study Record Updates

Last Update Posted (Actual)

April 12, 2018

Last Update Submitted That Met QC Criteria

April 10, 2018

Last Verified

April 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MANI-MTX02-001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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