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

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ClinicalTrials.gov Identifier: NCT01214317
Recruitment Status : Unknown
Verified August 2010 by Isfahan University of Medical Sciences.
Recruitment status was:  Active, not recruiting
First Posted : October 5, 2010
Last Update Posted : August 17, 2011
Sponsor:
Information provided by:
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

Condition or disease Intervention/treatment Phase
Multiple Sclerosis Procedure: plasmapheresis Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Study of Combinative Effect of Induction Therapy With Mitoxantrone and Plasmapheresis to Treat Patients With Aggressive Multiple Sclerosis
Study Start Date : January 2010
Estimated Primary Completion Date : January 2012
Estimated Study Completion Date : February 2012

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: mitoxantrone and plasmapheresis Procedure: 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 Names:
  • novantrone
  • plasma exchange

No Intervention: mitoxantrone



Primary Outcome Measures :
  1. expanded disability status score [ Time Frame: At the end of month 8 after treatment initiation ]
  2. number of MS plaques in brain MRI [ Time Frame: month 8 after treatment initiation ]

Secondary Outcome Measures :
  1. annual relapse rate [ Time Frame: month 17 after treatment initiation ]
  2. number of MS plaques in brain MRI [ Time Frame: month 17 after treatment initiation ]
  3. expanded disability status score [ Time Frame: month 17 after treatment initiation ]


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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01214317


Locations
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Iran, Islamic Republic of
Alahra hospital
Isfahan, Iran, Islamic Republic of
Sponsors and Collaborators
Isfahan University of Medical Sciences
Investigators
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Principal Investigator: Masoud Etemadifar Alzahra Hospital

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Responsible Party: Masoud Etemadifar, Isfahan university of medical sciences
ClinicalTrials.gov Identifier: NCT01214317     History of Changes
Other Study ID Numbers: 389050
First Posted: October 5, 2010    Key Record Dates
Last Update Posted: August 17, 2011
Last Verified: August 2010

Keywords provided by Isfahan University of Medical Sciences:
multiple sclerosis
mitoxantrone
plasmapheresis
induction therapy

Additional relevant MeSH terms:
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Mitoxantrone
Sclerosis
Multiple Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Antineoplastic Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action