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

Information source: Isfahan University of Medical Sciences
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Multiple Sclerosis

Intervention: plasmapheresis (Procedure)

Phase: N/A

Status: Active, not recruiting

Sponsored by: Isfahan University of Medical Sciences

Official(s) and/or principal investigator(s):
Masoud Etemadifar, Principal Investigator, Affiliation: Alzahra Hospital

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

Clinical Details

Official title: Study of Combinative Effect of Induction Therapy With Mitoxantrone and Plasmapheresis to Treat Patients With Aggressive Multiple Sclerosis

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome:

expanded disability status score

number of MS plaques in brain MRI

Secondary outcome:

annual relapse rate

number of MS plaques in brain MRI

expanded disability status score

Eligibility

Minimum age: 18 Years. Maximum age: 55 Years. Gender(s): Both.

Criteria:

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 and Contacts

Alahra hospital, Isfahan, Iran, Islamic Republic of
Additional Information

Starting date: January 2010
Last updated: August 16, 2011

Page last updated: August 23, 2015

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