NCT00232193

Safety/Effectiveness of Adding Monthly Dexamethasone to Weekly Avonex for MS

Steroid Adjunctive Treatment at Initiation of Avonex Therapy for Patients With Mono-Symptomatic or Relapsing-Remitting Multiple Sclerosis

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 40 (actual)
• Sponsor: Providence Multiple Sclerosis Center · Academic / Other
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Not accepted

Summary

The purpose of the study is to determine whether giving intravenous dexamethasone every 4 weeks during the first 12 months of weekly Avonex dosing will reduce the progression of functional impairment, brain atrophy, relapse rate and frequency, and new and enlarging brain lesions over the first 24 months of Avonex therapy in patients with relapsing-remitting or mono-symptomatic multiple sclerosis.

Detailed description

Beta Interferon-1a (Avonex)was approved by the FDA in 1996 to treat relapsing-remitting multiple sclerosis. Clinical trials have shown evidence in the reduction of relapses and progression of neurological and cognitive disability with the use of Avonex, as well as reduction in brain atrophy and new MS lesions on MRI were observed. Despite this, Avonex does not abolish disease activity, therefore, there is frequent need for adjunctive therapy, such as short courses of corticosteroids. This study will research the value of adding monthly pulsed corticosteroids as adjunctive therapy during the first year of Avonex use to determine: a)safety and tolerability b)if this therapy will reduce the progression of functional impairment, and c)if this therapy will reduce the progression of whole brain atrophy over a 13 month observation period.

Conditions

• Relapsing-remitting Multiple Sclerosis
• Clinically Isolated Syndrome

Timeline

• Start date: 2003-12-01
• Primary completion: 2008-12-01
• Completion: 2010-08-01
• First posted: 2005-10-04
• Last updated: 2011-07-22

Locations

1 site across 1 country: United States