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NCT00037115 · Status: WITHDRAWN · Phase: PHASE4 · Type: INTERVENTIONAL
Last updated 2018-04-12
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
Interventions
- DRUG
-
interferon beta 1a
- DRUG
-
methotrexate
- DRUG
-
methylprednisolone
Sponsors & Collaborators
-
Consultants in Neurology
collaborator INDUSTRY -
MidAmerica Neuroscience Research Foundation at Rowe Neurology Institute
lead OTHER
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 50 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2002-05-31
- Primary Completion
- 2002-12-31
- Completion
- 2002-12-31
Countries
- United States
Study Locations
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