Multiple Sclerosis
Conditions
Keywords
multiple sclerosis, mitoxantrone, plasmapheresis, induction therapy
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
Interventions
PROCEDUREplasmapheresis
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
Sponsors
Isfahan University of Medical Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Expanded Disability Status Score | 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. |
| Change From Baseline in Mean Number of MS Plaques Found on Brain MRI | Month 8 after treatment initiation | Change From Baseline in Mean Number of MS plaques found on Brain MRI 8 months after treatment initiation |
Countries
Iran
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Mitoxantrone and Plasmapheresis 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 | 18 |
| Mitoxantrone | 22 |
| Total | 40 |
Baseline characteristics
| Characteristic | Mitoxantrone and Plasmapheresis | Mitoxantrone | Total |
|---|---|---|---|
| Age, Continuous | 30.4 years STANDARD_DEVIATION 11.3 | 29.1 years STANDARD_DEVIATION 6.7 | 29.68 years STANDARD_DEVIATION 8.8 |
| Region of Enrollment Iran | 18 participants | 22 participants | 40 participants |
| Sex: Female, Male Female | 14 Participants | 17 Participants | 31 Participants |
| Sex: Female, Male Male | 4 Participants | 5 Participants | 9 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 18 | 0 / 22 |
| other Total, other adverse events | 6 / 18 | 7 / 22 |
| serious Total, serious adverse events | 0 / 18 | 0 / 22 |
Outcome results
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
Time frame: Month 8 after treatment initiation
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Mitoxantrone and Plasmapheresis | Change From Baseline in Mean Number of MS Plaques Found on Brain MRI | 3.5 Plaques | Standard Deviation 0.9 |
| Mitoxantrone | Change From Baseline in Mean Number of MS Plaques Found on Brain MRI | 7.3 Plaques | Standard Deviation 1.6 |
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.
Time frame: At the end of month 8 after treatment initiation
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Mitoxantrone and Plasmapheresis | Expanded Disability Status Score | 2.9 score on a scale | Standard Deviation 1.3 |
| Mitoxantrone | Expanded Disability Status Score | 2.6 score on a scale | Standard Deviation 0.9 |