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Completed

NCT Number: NCT01214317

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

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

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Key information

Conditions

Multiple Sclerosis Autoimmune Diseases Autoimmune Diseases of the Nervous System Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Immune System Diseases Nervous System Diseases

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Alahra hospital

Isfahan, Iran

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Plasmapheresis

Procedure

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

Primary outcomes

  1. Expanded Disability Status Score

    Time frame: At the end of month 8 after treatment initiation

    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.

  2. Change From Baseline in Mean Number of MS Plaques Found on Brain MRI

    Time frame: Month 8 after treatment initiation

    Change From Baseline in Mean Number of MS plaques found on Brain MRI 8 months after treatment initiation

Sponsors and collaborators

Lead sponsor

Isfahan University of Medical Sciences

Other

Registry information

Official study title

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

Acronym: IMPAMS

Important dates

Study start
2010
Primary completion
2012
Study completion
2012
First posted
Oct 5, 2010
Registry last updated
Sep 16, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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