Study of Induction Therapy With Mitoxantrone and Plasmapheresis to Treat Aggressive Multiple Sclerosis
NCT ID: NCT01214317
Last Updated: 2020-09-16
Study Results
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View full resultsBasic Information
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COMPLETED
NA
40 participants
INTERVENTIONAL
2010-01-31
2012-02-29
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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mitoxantrone and 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.
plasmapheresis
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
mitoxantrone
Monthly IV infusion of 12 mg/m2 mitoxantrone (EBEWE Pharma, Amsterdam, The Netherlands) for three successive months. Then, treatment is continued by adding two more 6 mg/m2 doses of mitoxantrone in 3-month intervals.
No interventions assigned to this group
Interventions
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plasmapheresis
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
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* Severe drug induced side effects
18 Years
55 Years
ALL
No
Sponsors
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Isfahan University of Medical Sciences
OTHER
Responsible Party
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Masoud Etemadifar
Professor of neurology
Principal Investigators
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Masoud Etemadifar
Role: PRINCIPAL_INVESTIGATOR
Alzahra Hospital
Locations
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Alahra hospital
Isfahan, , Iran
Countries
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Other Identifiers
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389050
Identifier Type: -
Identifier Source: org_study_id
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