Study of Induction Therapy With Mitoxantrone and Plasmapheresis to Treat Aggressive Multiple Sclerosis

Isfahan University of Medical Sciences40 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Multiple Sclerosis

Interventions

plasmapheresisPROCEDURE

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 55 Years

Medical Language ↔ Plain English

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

Locations (1)

Alahra hospital

Isfahan, Iran

Outcomes

Primary Outcomes

Expanded Disability Status Score

The Kurtzke Expanded Disability Status Scale (EDSS) is a method of quantifying disability in multiple sclerosis and defines functional systems as pyramidalm, cerebellar, brainstem, sensory, bowel and bladder, visual, cerebral and others. The EDSS scale ranges from 0 to 10 in 0.5 unit increments that represent higher levels of disability.

Time frame: At the end of month 8 after treatment initiation

Change From Baseline in Mean Number of MS Plaques Found on Brain MRI

Change From Baseline in Mean Number of MS plaques found on Brain MRI 8 months after treatment initiation

Time frame: Month 8 after treatment initiation

Data from ClinicalTrials.gov

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