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

Primary Purpose

Multiple Sclerosis

Status
Completed
Phase
Not Applicable
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
plasmapheresis
Sponsored by
Isfahan University of Medical Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Multiple Sclerosis focused on measuring multiple sclerosis, mitoxantrone, plasmapheresis, induction therapy

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesDoes not accept 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

Sites / Locations

  • Alahra hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

mitoxantrone and plasmapheresis

mitoxantrone

Arm 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.

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.

Outcomes

Primary Outcome Measures

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.
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

Secondary Outcome Measures

Full Information

First Posted
October 4, 2010
Last Updated
August 27, 2020
Sponsor
Isfahan University of Medical Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT01214317
Brief Title
Study of Induction Therapy With Mitoxantrone and Plasmapheresis to Treat Aggressive Multiple Sclerosis
Acronym
IMPAMS
Official Title
Study of Combinative Effect of Induction Therapy With Mitoxantrone and Plasmapheresis to Treat Patients With Aggressive Multiple Sclerosis
Study Type
Interventional

2. Study Status

Record Verification Date
August 2020
Overall Recruitment Status
Completed
Study Start Date
January 2010 (Actual)
Primary Completion Date
January 2012 (Actual)
Study Completion Date
February 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Isfahan University of Medical Sciences

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis
Keywords
multiple sclerosis, mitoxantrone, plasmapheresis, induction therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
mitoxantrone and plasmapheresis
Arm Type
Active Comparator
Arm 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.
Arm Title
mitoxantrone
Arm Type
No Intervention
Arm 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.
Intervention Type
Procedure
Intervention Name(s)
plasmapheresis
Other Intervention Name(s)
novantrone, plasma exchange
Intervention Description
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
Primary Outcome Measure Information:
Title
Expanded Disability Status Score
Description
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
Title
Change From Baseline in Mean Number of MS Plaques Found on Brain MRI
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Masoud Etemadifar
Organizational Affiliation
Alzahra Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Alahra hospital
City
Isfahan
Country
Iran, Islamic Republic of

12. IPD Sharing Statement

Learn more about this trial

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

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