Study to Evaluate Intravenous and Oral Steroids for Multiple Sclerosis Attacks

• Status: Terminated
• Trial end date: 2013-10-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Fred Lublin
• Collaborators: National Multiple Sclerosis Society; Pfizer
• Treatments: Methylprednisolone; Methylprednisolone Acetate; Methylprednisolone Hemisuccinate; Prednisolone; Prednisolone acetate; Prednisolone hemisuccinate; Prednisolone phosphate

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.