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

Not Applicable

Completed

• Conditions: Multiple Sclerosis
• Interventions: Procedure: plasmapheresis

• Registration Number: NCT01214317
• Lead Sponsor: Isfahan University of Medical Sciences

Brief 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

Detailed Description

Not available

Study Timeline

• Study Start: 2010-01
• Study First Submitted: 2010-10-04
• Study First Submitted QC: 2010-10-04
• Study First Posted: 2010-10-05
• Primary Completion: 2012-01
• Study Completion: 2012-02
• Status Verified: 2020-08
• Results First Submitted: 2020-08-11
• Results First Submitted QC: 2020-08-27
• Last Update Submitted: 2020-08-27
• Results First Posted: 2020-09-16
• Last Update Posted: 2020-09-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
mitoxantrone and plasmapheresis	plasmapheresis	Monthly Plasmapheresis (plasma exchange machine: Haemonetics, model TCS2, USA) 25 ml/kg for 5 cycles, with replacement of 0.9% saline and 5% human serum albumin followed by monthly IV infusion of 12 mg/m2 mitoxantrone (EBEWE Pharma, Amsterdam, The Netherlands) at the end of each Plasmapheresis course for three successive months. Then, treatment is continued by adding two more 6 mg/m2 doses of mitoxantrone in 3-month intervals.

Primary Outcome Measures

Name	Time	Method
Change From Baseline in Mean Number of MS Plaques Found on Brain MRI	Month 8 after treatment initiation	Change From Baseline in Mean Number of MS plaques found on Brain MRI 8 months after treatment initiation
Expanded Disability Status Score	At the end of month 8 after treatment initiation	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.

Trial Locations

Locations (1)

Alahra hospital; 🇮🇷 Isfahan, Iran, Islamic Republic of