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The purpose of this study is to show the dose-response relationship of three doses of mitoxantrone with regard to efficacy in patients with secondary progressive multiple sclerosis and to show the safety and tolerability of mitoxantrone in these patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | 1st group: 12 mg Mitoxantrone/m² |
|
| 2 | Experimental | 2nd group: 9mg Mitoxantrone/m² |
|
| 3 | Experimental | 3rd group: 5mg Mitoxantrone/m² |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mitoxantrone | Drug | dosage |
|
| Measure | Description | Time Frame |
|---|---|---|
| 3 clinical measures combined in a multivariate analysis: confirmed Expanded Disability Status Scale(EDSS) | 3 years | |
| deterioration, change of ambulation index, time to first relapse requiring corticoid treatment | 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| derivations of EDSS and relapses; MRI (baseline, 2 years) | 3 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Monitor | Wyeth is now a wholly owned subsidiary of Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Berg | D-82335 | Germany | ||||
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| ID | Term |
|---|---|
| D020528 | Multiple Sclerosis, Chronic Progressive |
| D009103 | Multiple Sclerosis |
| ID | Term |
|---|---|
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D003711 | Demyelinating Diseases |
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| ID | Term |
|---|---|
| D008942 | Mitoxantrone |
| ID | Term |
|---|---|
| D000880 | Anthraquinones |
| D000095322 | Anthrones |
| D000873 | Anthracenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
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| Berlin |
| D-13347 |
| Germany |
| Düsseldorf | D-40225 | Germany |
| Düsseldorf | D-40479 | Germany |
| Giessen | D-35385 | Germany |
| Marburg | D-35039 | Germany |
| Wiesbaden | D-65191 | Germany |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006841 |
| Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011809 | Quinones |
| D011083 | Polycyclic Compounds |