Efficacy of Cyclophosphamide Versus Methylprednisolone in Patients With Secondary Progressive Multiple Sclerosis
Status:
Completed
Trial end date:
2012-03-01
Target enrollment:
Participant gender:
Summary
Preliminary not-controlled clinical studies of the efficacy of monthly intravenous
cyclophosphamide administration in secondary progressive multiple sclerosis reported
encouraging results, but no randomized controlled trial has been conducted so far. The
primary objective of this trial is to evaluate the efficacy of IV cyclophosphamide as
compared to IV methylprednisolone administered every 4 weeks during 1 year and every 8 weeks
during 1 year, on the delay to confirmed disability deterioration as assessed by the Expanded
Disability Status Scale (EDSS) in patients with secondary progressive multiple sclerosis. The
secondary objectives are to evaluate safety, tolerability and efficacy at 2 years on the
Multiple Sclerosis Functional Composite (MSFC), the percentage of patients with disability
deterioration (EDSS) and the number of relapses. An intention-to-treat statistical analysis
will be carried out.