Overview

This trial is active, not recruiting.

Condition multiple sclerosis
Treatment plasmapheresis
Sponsor Isfahan University of Medical Sciences
Start date January 2010
End date January 2012
Trial size 40 participants
Trial identifier NCT01214317, 389050

Summary

The purpose of this study is to compare the effect of combinative induction therapy with mitoxantrone and plasmapheresis versus induction therapy with mitoxantrone alone in cases of aggressive multiple sclerosis

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Active Comparator)
plasmapheresis novantrone
3 courses of plasmapheresis are performed before mitoxantrone injection in first 3 months to investigate the efficacy of plasmapheresis in comparison with the other arm that are only treated with mitoxantrone
(No Intervention)

Primary Outcomes

Measure
expanded disability status score
time frame: At the end of month 8 after treatment initiation
number of MS plaques in brain MRI
time frame: month 8 after treatment initiation

Secondary Outcomes

Measure
annual relapse rate
time frame: month 17 after treatment initiation
number of MS plaques in brain MRI
time frame: month 17 after treatment initiation
expanded disability status score
time frame: month 17 after treatment initiation

Eligibility Criteria

Male or female participants from 18 years up to 55 years old.

Inclusion Criteria: - Aggressive multiple sclerosis in attack phase - EDSS: 1-5 - No contraindication for mitoxantrone prescription - No past history of mitoxantrone injection - No history of corticosteroid and immunosuppressive therapy in last 3 months Exclusion Criteria: - Patient's incompliance - Severe drug induced side effects

Additional Information

Official title Study of Combinative Effect of Induction Therapy With Mitoxantrone and Plasmapheresis to Treat Patients With Aggressive Multiple Sclerosis
Principal investigator Masoud Etemadifar
Trial information was received from ClinicalTrials.gov and was last updated in August 2011.
Information provided to ClinicalTrials.gov by Isfahan University of Medical Sciences.