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

Multiple Sclerosis Clinical Trial

— IMPAMS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01214317
• Other study ID #: 389050
• Status: Completed
• Phase: N/A
• Start date: January 2010
• Est. completion date: February 2012

Study information

• Verified date: August 2020
• Source: Isfahan University of Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: February 2012
• Est. primary completion date: January 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Multiple Sclerosis
• Sclerosis

Intervention

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

Locations

Country	Name	City	State
Iran, Islamic Republic of	Alahra hospital	Isfahan

Sponsors (1)

Lead Sponsor	Collaborator
Isfahan University of Medical Sciences

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	At the end of month 8 after treatment initiation
Primary	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	Month 8 after treatment initiation