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Sponsored by: |
Wyeth |
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Information provided by: | Wyeth |
ClinicalTrials.gov Identifier: | NCT00146159 |
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.
Condition | Intervention | Phase |
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Secondary Progressive Multiple Sclerosis |
Drug: Mitoxantrone |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Dose Comparison, Parallel Assignment, Efficacy Study |
Official Title: | A Double-Blind, Three-Armed, Randomized Phase-III-Study, to Compare the Efficacy, Tolerability and Safety of Three Doses of Mitoxantrone in the Treatment of Patients With Secondary Progressive Multiple Sclerosis |
Estimated Enrollment: | 336 |
Study Start Date: | March 2005 |
Primary Completion Date: | September 2007 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
1st group: 12 mg Mitoxantrone/m²
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Drug: Mitoxantrone
dosage
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2: Experimental
2nd group: 9mg Mitoxantrone/m²
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Drug: Mitoxantrone
dosage
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3: Experimental
3rd group: 5mg Mitoxantrone/m²
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Drug: Mitoxantrone
dosage
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Ages Eligible for Study: | 18 Years to 55 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Germany | |
Wiesbaden, Germany, D-65191 | |
Marburg, Germany, D-35039 | |
Gießen, Germany, D-35385 | |
Düsseldorf, Germany, D-40479 | |
Berlin, Germany, D-13347 | |
Berg, Germany, D-82335 | |
Düsseldorf, Germany, D-40225 |
Study Director: | Medical Monitor | Wyeth |
Responsible Party: | Wyeth ( Wyeth (Clinical Trials Registry Specialist) ) |
Study ID Numbers: | 0906E-100925 |
Study First Received: | September 1, 2005 |
Last Updated: | December 21, 2007 |
ClinicalTrials.gov Identifier: | NCT00146159 History of Changes |
Health Authority: | Germany: Federal Institute for Drugs and Medical Devices |
Multiple Sclerosis |
Autoimmune Diseases Multiple Sclerosis Demyelinating Diseases Neoplasm Metastasis Demyelinating Autoimmune Diseases, CNS Sclerosis |
Peripheral Nervous System Agents Analgesics Mitoxantrone Autoimmune Diseases of the Nervous System Multiple Sclerosis, Chronic Progressive |
Autoimmune Diseases Demyelinating Diseases Immune System Diseases Antineoplastic Agents Physiological Effects of Drugs Nervous System Diseases Sclerosis Pharmacologic Actions Multiple Sclerosis, Chronic Progressive Neoplastic Processes Neoplasms |
Multiple Sclerosis Pathologic Processes Sensory System Agents Therapeutic Uses Neoplasm Metastasis Demyelinating Autoimmune Diseases, CNS Peripheral Nervous System Agents Analgesics Mitoxantrone Central Nervous System Agents Autoimmune Diseases of the Nervous System |