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

Isfahan University of Medical Sciences

Status: Completed

Conditions: Multiple Sclerosis

Treatments: Procedure: plasmapheresis

Study type: Interventional

Funder types: Other

Identifiers

NCT01214317

389050

Details and patient eligibility

About

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

Enrollment: 40 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

mitoxantrone and plasmapheresis

Active Comparator group

Description:

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.

Treatment:

Procedure: plasmapheresis

mitoxantrone

No Intervention group

Description:

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.