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.

NCT00037115 | Withdrawn Phase 4

• 1 other identifier: MANI-MTX02-001
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Demyelinating Disorders; Multiple Sclerosis; Optic Neuritis; Myelitis; Neuritis

Keywords

Demyelinating; Multiple Sclerosis; Myelitis; Neuritis; Optic Neuritis; AVONEX; methotrexate; methylprednisolone; interferon beta 1a; demyelination; central nervous system; brain; nerve; lesions; enhancement; enhancing

Interventions

interferon beta 1a DRUG

methotrexate DRUG

methylprednisolone DRUG

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

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.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• MidAmerica Neuroscience Research Foundation at Rowe Neurology Institute: lead
• Consultants in Neurology: collaborator

Study Sites (1)

MidAmerica Neuroscience Institute

Kansas City, Missouri, 64108, United States

Location

MeSH Terms

Conditions

Demyelinating Diseases; Multiple Sclerosis; Optic Neuritis; Myelitis; Neuritis

Interventions

Interferon beta-1a; Methotrexate; Methylprednisolone

Condition Hierarchy (Ancestors)

Nervous System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Autoimmune Diseases; Immune System Diseases; Optic Nerve Diseases; Cranial Nerve Diseases; Eye Diseases; Central Nervous System Infections; Infections; Central Nervous System Diseases; Spinal Cord Diseases; Neuroinflammatory Diseases; Peripheral Nervous System Diseases; Neuromuscular Diseases

Intervention Hierarchy (Ancestors)

Interferon-beta; Interferon Type I; Interferons; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors; Aminopterin; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Prednisolone; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Vernon D. Rowe III, MD

Study Record Dates

• First Submitted: May 15, 2002
• First Posted: May 17, 2002
• Study Start: May 1, 2002
• Primary Completion: December 1, 2002
• Study Completion: December 1, 2002
• Last Updated: April 12, 2018

Record last verified: 2018-04

Locations

US (1)