A Phase 3 interventional study of Cyclophosphamide (drug) and Methylprednisolone (drug) in Multiple Sclerosis, Chronic Progressive, sponsored by University Hospital, Bordeaux. Completed at 26 sites in France. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2012-03-15.
Sponsored by University Hospital, Bordeaux · Phase 3, Interventional, and Treatment
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.
Background
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. A slight efficacy of Methylprednisolone has been reported in this indication.
Objectives
The primary objective is to evaluate the efficacy of IV cyclophosphamide on the prevention of disability deterioration in patients with secondary progressive multiple sclerosis.
The secondary objectives are to evaluate safety, tolerability and efficacy of IV cyclophosphamide on the Multiple Sclerosis Functional Composite (MSFC) and the number of relapses.
Study design
Randomized double-blind two-arm controlled trial.
Intervention
Experimental group : IV cyclophosphamide infusion administered every 4 weeks during 1 year and every 8 weeks during 1 year.
Control group : IV methylprednisolone infusion administered every 4 weeks during 1 year and every 8 weeks during 1 year.
Outcomes
Primary outcome : delay to disability deterioration as assessed by the Expanded Disability Status Scale (EDSS: 0.5 or 1 point increase, depending on baseline score) evaluated every 4 weeks for one year, then every 8 weeks for one year.
Secondary outcomes : proportion of patients with disability deterioration (EDSS: 0.5 or 1 point increase, depending on baseline score), Multiple Sclerosis Functional Composite (MSFC) and the Z scores of MSFC three components, number of MS relapses, proportion of patients with adverse events and delay of occurrence of adverse events, quality of life questionnaires.
Sample size
360 patients
Statistical analysis
Intention-to-treat analysis.
3,460 studies on the registry are indexed under Multiple Sclerosis; 661 are open to participants now.
This study's enrollment of 138 is above the median of 50 across 2,342 interventional studies indexed under Multiple Sclerosis.
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Exclusion Criteria:
Cyclophosphamide
Drug: Cyclophosphamide (drug)
Methylprednisolone
Drug: Methylprednisolone (drug)
IV cyclophosphamide infusion administered every 4 weeks during 1 year and every 8 weeks during 1 year.
Control group : IV methylprednisolone infusion administered every 4 weeks during 1 year and every 8 weeks during 1 year.
Delay to disability deterioration as assessed by the Expanded Disability Status Scale (EDSS: 0.5 or 1 point increase, depending on baseline score)
Time frame: every 4 weeks for one year, then every 8 weeks for one year
Proportion of patients with disability deterioration (EDSS: 0.5 or 1 point increase, depending on baseline score)
Time frame: every month during one year then every two months during the 2nd year
Multiple Sclerosis Functional Composite (MSFC) and the Z scores of MSFC three components
Time frame: Visit number 1, 2, 13(at one year),19 (at two years) and 20 (last visit)
Number of MS relapses
Time frame: all along the follow up period
Proportion of patients with adverse events and delay of occurrence of adverse events
Time frame: all along the follow up period
Quality of life questionnaires
Time frame: visit 2, 13(at one year) and 19 (at two years)
Disability self-assessment questionnaires
Time frame: visite 2, 13 et 19
This study is completed, as verified in Mar 2012. You cannot join it, but the record below documents what was studied.
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University Hospital, Bordeaux