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Efficacy of Cyclophosphamide Versus Methylprednisolone in Patients With Secondary Progressive Multiple Sclerosis

NCT00241254 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 138

Last updated 2012-03-15

No results posted yet for this study

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.

Conditions

  • Multiple Sclerosis, Chronic Progressive

Interventions

DRUG

Cyclophosphamide (drug)

IV cyclophosphamide infusion administered every 4 weeks during 1 year and every 8 weeks during 1 year.

DRUG

Methylprednisolone (drug)

Control group : IV methylprednisolone infusion administered every 4 weeks during 1 year and every 8 weeks during 1 year.

Sponsors & Collaborators

  • Ministry of Health, France

    collaborator OTHER_GOV

  • University Hospital, Bordeaux

    lead OTHER

Principal Investigators

  • Bruno Brochet, Professor · University Hospital, Bordeaux, France

  • Paul Perez, Dr · University Hospital, Bordeaux, France

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-12-31
Primary Completion
2010-03-31
Completion
2012-03-31

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00241254 on ClinicalTrials.gov