Ignite Creation Date:
2024-05-05 @ 12:06 PM
Last Modification Date:
2024-10-26 @ 9:20 AM
Study NCT ID:
NCT00241254
Status:
COMPLETED
Last Update Posted:
2012-03-15
First Post:
2005-10-17
Brief Title:
Efficacy of Cyclophosphamide Versus Methylprednisolone in Patients With Secondary Progressive Multiple Sclerosis
Sponsor:
University Hospital Bordeaux
Organization:
University Hospital Bordeaux
Study Overview
Official Title:
A Double-blind Two-arm Multicenter Randomized Trial to Evaluate Efficacy of Cyclophosphamide Versus Methylprednisolone in Patients With Recent Secondary Progressive Multiple Sclerosis PROMESS Study
Status:
COMPLETED
Status Verified Date:
2012-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PROMESS
Brief 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
Detailed Description:
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 05 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 05 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
Quality of life questionnaires
Disability self-assessment questionnaires Main time of assessment 2 years
Sample size
360 patients
Statistical analysis
Intention-to-treat analysis
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 05 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 05 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
Quality of life questionnaires
Disability self-assessment questionnaires Main time of assessment 2 years
Sample size
360 patients
Statistical analysis
Intention-to-treat analysis
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2004-005 | None | None | None |