Study to Evaluate Intravenous and Oral Steroids for Multiple Sclerosis Attacks

Stopped early · Phase 3

Conditions studied: Multiple Sclerosis

In brief

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.

Key facts

Study ID

NCT00418145

Run by

Fred Lublin

People needed

16

Starts

2003-09-01

Expected to finish

2013-10-01

Last updated by the study team

2017-05-18

Who can join

Age: 18 and older, up to 50. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• University of Medicine and Dentistry of New Jersey — New Brunswick, New Jersey, United States
• Maimonides Medical Center — Brooklyn, New York, United States
• The Jacobs Neurological Institute — Buffalo, New York, United States
• Hospital For Joint Diseases — New York, New York, United States
• St. Luke's Roosevelt — New York, New York, United States
• Icahn School of Medicine at Mount Sinai — New York, New York, United States
• Columbia University Medical Center — New York, New York, United States
• NY Presbyterian Hospital-Cornell University New York — New York, New York, United States
• University of Rochester — Rochester, New York, United States
• University of Vermont, Burlington — Burlington, Vermont, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.