NCT00418145

Study to Evaluate Intravenous and Oral Steroids for Multiple Sclerosis Attacks

Oral Megadose Corticosteroid Therapy of Acute Exacerbations of Multiple Sclerosis (OMEGA)

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: Fred Lublin · Academic / Other
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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.

Conditions

• Multiple Sclerosis

Interventions

Type	Name	Description
DRUG	megadose oral methylprednisolone	1400 mg qd/5 days
DRUG	IV methylprednisolone	1000 mg/qd/5 days

Timeline

• Start date: 2003-09-01
• Primary completion: 2013-10-01
• Completion: 2013-10-01
• First posted: 2007-01-04
• Last updated: 2017-05-18
• Results posted: 2017-05-18

Locations

10 sites across 1 country: United States