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.
Demyelinating Disorders, Multiple Sclerosis, Optic Neuritis
About this trial
This is an interventional treatment trial for Demyelinating Disorders focused on measuring Demyelinating, Multiple Sclerosis, Myelitis, Neuritis, Optic Neuritis, AVONEX, methotrexate, methylprednisolone, interferon beta 1a, demyelination, central nervous system, brain, nerve, lesions, enhancement, enhancing
Eligibility Criteria
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.
Sites / Locations
- MidAmerica Neuroscience Institute