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Methotrexate Induction Prior to Avonex in First Demyelinating Event
NCT00037115Phase 4
Key facts
- Status
- Withdrawn
- Start
- May 2002
- Primary completion
- Dec 2002
- Countries
- 1
- Modality
- Orthosteric Ligands
- Drugs
- methotrexate
- Conditions
- clinically isolated syndrome (CIS)multiple sclerosis (MS)
01
Overview
Phase 4, open-label, single-arm trial of methotrexate in clinically isolated syndrome (CIS) and multiple sclerosis (MS), sponsored by MidAmerica Neuroscience Research Foundation. Planned start May 2002; status: withdrawn.
02
Design
1 arm- Study design
- Non-randomizedOpen-label
Methotrexate Induction + Avonex
Single high dose IV methotrexate induction followed by weekly Avonex maintenance
03
Who it enrols
Patients aged 18-50 with a first isolated, well-defined neurologic event consistent with demyelination (optic neuritis, myelitis, or brain stem/cerebellar syndrome) and two or more clinically silent MRI lesions >= 3mm. Symptoms must have started <= 12 days before methotrexate treatment.
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