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

NCT01214317 | Completed Results DMC

• 1 other identifier: 389050
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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

Conditions

Multiple Sclerosis

Keywords

multiple sclerosis; mitoxantrone; plasmapheresis; induction therapy

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Study Arms (2)

mitoxantrone and plasmapheresis

ACTIVE COMPARATOR

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.

Procedure: plasmapheresis

mitoxantrone

NO INTERVENTION

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.

Interventions

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

Also known as: novantrone, plasma exchange

mitoxantrone and plasmapheresis

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• Patient's incompliance
• Severe drug induced side effects

Sponsors & Collaborators

• Isfahan University of Medical Sciences: lead

Study Sites (1)

Alahra hospital

Isfahan, Iran

Location

MeSH Terms

Conditions

Multiple Sclerosis

Interventions

Plasmapheresis; Mitoxantrone; Plasma Exchange

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Blood Component Removal; Therapeutics; Sorption Detoxification; Extracorporeal Circulation; Surgical Procedures, Operative; Anthraquinones; Anthrones; Anthracenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Quinones; Polycyclic Compounds; Blood Transfusion; Biological Therapy

Results Point of Contact

• Title: Director of clinical trial
• Organization: Isfahan University of medical sciences

etemadifar.m@gmail.com

+983136202020

Study Officials

• Masoud Etemadifar

  Alzahra Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of neurology

Study Record Dates

• First Submitted: October 4, 2010
• First Posted: October 5, 2010
• Study Start: January 1, 2010
• Primary Completion: January 1, 2012
• Study Completion: February 1, 2012
• Last Updated: September 16, 2020
• Results First Posted: September 16, 2020

Record last verified: 2020-08

Locations

IR (1)