IMPAMS
What it found
Results are posted in the registry, but without a statistical test of the main measure. See the numbers below.
What was tested
Treatment tested
- plasmapheresis
Results by group
Expanded Disability Status Score
At the end of month 8 after treatment initiation
| Group | Value | Interval | Number analysed |
|---|---|---|---|
| Mitoxantrone and Plasmapheresis | 2.9 score on a scale | 1.3 (Standard Deviation) | 18 |
| Mitoxantrone | 2.6 score on a scale | 0.9 (Standard Deviation) | 22 |
Mitoxantrone and Plasmapheresis
Mitoxantrone
Change From Baseline in Mean Number of MS Plaques Found on Brain MRI
Month 8 after treatment initiation
| Group | Value | Interval | Number analysed |
|---|---|---|---|
| Mitoxantrone and Plasmapheresis | 3.5 Plaques | 0.9 (Standard Deviation) | 18 |
| Mitoxantrone | 7.3 Plaques | 1.6 (Standard Deviation) | 22 |
Mitoxantrone and Plasmapheresis
Mitoxantrone
Values as posted on ClinicalTrials.gov. Outcomes measured differently across trials are not directly comparable.
Safety
| Group | Participants at risk | Serious adverse events | Deaths |
|---|---|---|---|
| Mitoxantrone and Plasmapheresis | 18 | 0 (0.0%) | 0 |
| Mitoxantrone | 22 | 0 (0.0%) | 0 |
As posted on ClinicalTrials.gov. Serious adverse events include any serious health event during the trial, whether or not the treatment caused it.
What it measured
Main measures
Expanded Disability Status Score
At the end of month 8 after treatment initiation
Disability progressionBladder, bowel and sexual functionChange From Baseline in Mean Number of MS Plaques Found on Brain MRI
Month 8 after treatment initiation
MRI lesions
Who could take part
MS (type not specified) · 18 to 55
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
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
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
Papers
Loading reviews and guidelines…
Related trials
- Phase III Randomized, Double-Blind, Sham-Controlled Study…
Phase 3 · Status unknown
No result found
History
Started
Jan 2010
Main results due
Jan 2012
Finished
Feb 2012
Results posted
Sept 2020
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