Study to Evaluate Intravenous and Oral Steroids for Multiple Sclerosis Attacks
Condition: Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Sclerosis
Intervention: megadose oral methylprednisolone; IV methylprednisolone
Intervention description: 1400 mg qd/5 days; 1000 mg/qd/5 days
Intervention MeSH terms: Methylprednisolone; Methylprednisolone Acetate; Methylprednisolone Hemisuccinate; Prednisolone; Prednisolone acetate; Prednisolone hemisuccinate; Prednisolone phosphate
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 16.0
Sex: All
Minimum age: 18 Years
Maximum age: 50 Years
Healthy volunteers: No
Keywords: Relapsing Forms of Multiple Sclerosis

Summary:

      This clinical trial compares the relative efficacy of treating acute exacerbations of
      relapsing forms of Multiple Sclerosis with equivalent doses of oral and intravenous (IV)
      methylprednisolone. This is a randomized, blinded, multi-center study.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Between the ages of 18 and 50 years, inclusive.

          -  Acute symptomatic exacerbation of MS present for great than 24 hours and less than or
             equal to 7 days at entry with new or worsening symptoms, and with signs referable to
             the symptoms; in the absence of a fever or active infection.

          -  Diagnosis of a relapsing form of multiple sclerosis before randomization as determined
             by Poser or McDonald Criteria.

          -  Expanded disability status scale (EDSS) score between 2 and 6.5, inclusive at entry.

          -  Episodes include study neurologist or neuro-ophthalmologist diagnosed: acute optic
             neuritis, cerebellar, brainstem dysfunction, myelitis, focal cerebral, and/or
             definitive focal sensory dysfunction.

          -  New objective clinical finding other than a sensory exacerbation, or bowel/bladder
             signs alone. Sensory deficits alone will not qualify except for optic neuritis.

          -  Subjects may continue on their current immunomodulating therapy (such as interferons
             or glatiramer acetate) throughout the course of the study. Women who become pregnant
             after the 5-day treatment of steroids should discontinue immunomodulatory treatment.

          -  Understand and sign 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.

        Exclusion Criteria:

          -  Any patients treated with systemic corticosteroid use within one month of the index
             episode at screening.

          -  Prior use of immunosuppressive treatments within 90 days of index episode
             (mitoxantrone, azathioprine, IVIg) or plasmapheresis.

          -  Any patient who is pregnant or breastfeeding.

          -  Unable to perform the Multiple Sclerosis Functional Composite consisting of: Timed
             25-Foot Walk, 9-Hole Peg Test, and Paced Auditory Serial Addition Test (3 second).

          -  Peripheral or cranial neuropathy as sole problem of acute episode.

          -  History of any significant cardiac, gastrointestinal, hepatic, pulmonary, or renal
             disease; immune deficiency; or other medical conditions that would preclude
             corticosteroid therapy.

          -  Primary Progressive Multiple Sclerosis (PPMS).

          -  Previous participation in this study.