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Sponsors and Collaborators: |
Mount Sinai School of Medicine National Multiple Sclerosis Society Pfizer |
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Information provided by: | Mount Sinai School of Medicine |
ClinicalTrials.gov Identifier: | NCT00418145 |
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.
Condition | Intervention | Phase |
---|---|---|
Multiple Sclerosis |
Drug: megadose oral methylprednisolone Drug: IV methylprednisolone |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study |
Official Title: | Oral Megadose Corticosteroid Therapy of Acute Exacerbations of Multiple Sclerosis (OMEGA) |
Estimated Enrollment: | 120 |
Study Start Date: | September 2003 |
Estimated Primary Completion Date: | December 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental |
Drug: megadose oral methylprednisolone
1400 mg qd/5 days
|
2: Experimental |
Drug: IV methylprednisolone
1000 mg/qd/5 days
|
Intravenous methylprednisolone has been the standard of care for treating acute MS flares. However, the IV administration is cumbersome, inconvenient and expensive. A true comparison of these different approaches has not been undertaken in rigorous fashion. Prior studies have demonstrated the safety of such high doses of oral steroid. For this proposal we employ equivalent oral dosing (1400 mg/day) and compare that to 1000 mg/day IV therapy in patients seen within seven days of an acute exacerbation of MS.
In addition, there are 2 arms to this double-blind, placebo controlled, randomized trial. One arm has an active IV and an oral placebo while the second arm has an IV placebo and an active oral dose. Therefore, each subject will receive an active treatment.
Ages Eligible for Study: | 18 Years to 50 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Michele Weber | 212-241-4264 | Michele.Weber@msnyuhealth.org |
United States, New Jersey | |
University of Medicine and Dentistry of New Jersey | Suspended |
New Brunswick, New Jersey, United States | |
United States, New York | |
Mount Sinai School of Medicine | Recruiting |
New York, New York, United States, 10029 | |
Contact: Michele Weber 212-241-4264 Michele.Weber@msnyuhealth.org | |
Principal Investigator: Fred Lublin, MD | |
Sub-Investigator: Aaron Miller, MD | |
Maimonides Medical Center | Suspended |
Brooklyn, New York, United States | |
Hospital For Joint Diseases | Suspended |
New York, New York, United States | |
St. Luke's Roosevelt | Suspended |
New York, New York, United States | |
Columbia University Medical Center | Suspended |
New York, New York, United States | |
The Jacobs Neurological Institute | Suspended |
Buffalo, New York, United States | |
NY Presbyterian Hospital-Cornell University New York | Suspended |
New York, New York, United States | |
University of Rochester | Suspended |
Rochester, New York, United States | |
United States, Vermont | |
University of Vermont, Burlington | Suspended |
Burlington, Vermont, United States |
Principal Investigator: | Fred Lublin, MD | Mount Sinai School of Medicine |
Responsible Party: | Mount School of Medicine ( Fred Lublin, MD ) |
Study ID Numbers: | RG 3363A8, 01-0781 |
Study First Received: | January 2, 2007 |
Last Updated: | December 30, 2008 |
ClinicalTrials.gov Identifier: | NCT00418145 |
Health Authority: | United States: Food and Drug Administration |
Relapsing Forms of Multiple Sclerosis |
Autoimmune Diseases Multiple Sclerosis Demyelinating Diseases Methylprednisolone Prednisolone Methylprednisolone acetate |
Demyelinating Autoimmune Diseases, CNS Prednisolone acetate Demyelinating diseases Sclerosis Autoimmune Diseases of the Nervous System Methylprednisolone Hemisuccinate |
Anti-Inflammatory Agents Antineoplastic Agents, Hormonal Immune System Diseases Antineoplastic Agents Nervous System Diseases Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Gastrointestinal Agents Antiemetics Hormones |
Glucocorticoids Protective Agents Neuroprotective Agents Pharmacologic Actions Pathologic Processes Autonomic Agents Therapeutic Uses Peripheral Nervous System Agents Central Nervous System Agents |