N/A
N=40
Study of Induction Therapy With Mitoxantrone and Plasmapheresis to Treat Aggressive Multiple Sclerosis
Multiple Sclerosis
Bottom Line
View on ClinicalTrials.gov: NCT01214317 ↗Enrolled (actual)
40
Serious AEs
0.0%
Results posted
Sep 2020
Primary outcome: Primary: Expanded Disability Status Score — 2.9; 2.6 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- plasmapheresis (Procedure)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Isfahan University of Medical Sciences
- Primary completion
- Jan 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Expanded Disability Status Score |
2.9; 2.6 | — |
| PRIMARY Change From Baseline in Mean Number of MS Plaques Found on Brain MRI |
3.5; 7.3 | — |
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
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
Data sourced from ClinicalTrials.gov (NCT01214317). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.