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Study Evaluating Mitoxantrone in Multiple Sclerosis

Information source: Wyeth is now a wholly owned subsidiary of Pfizer
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Secondary Progressive Multiple Sclerosis

Intervention: Mitoxantrone (Drug)

Phase: Phase 3

Status: Terminated

Sponsored by: Wyeth is now a wholly owned subsidiary of Pfizer

Official(s) and/or principal investigator(s):
Medical Monitor, Study Director, Affiliation: Wyeth is now a wholly owned subsidiary of Pfizer

Summary

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.

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome:

3 clinical measures combined in a multivariate analysis: confirmed Expanded Disability Status Scale(EDSS)

deterioration, change of ambulation index, time to first relapse requiring corticoid treatment

Secondary outcome: derivations of EDSS and relapses; MRI (baseline, 2 years)

Eligibility

Minimum age: 18 Years. Maximum age: 55 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Secondary progressive MS in an active stage

- EDSS between 3 and 6

Exclusion Criteria:

- Benign or primary progressive MS

- Patients with cardiac risk factors

- Patients who have already received mitoxantrone

Locations and Contacts

Berg D-82335, Germany

Berlin D-13347, Germany

Düsseldorf D-40225, Germany

Düsseldorf D-40479, Germany

Gießen D-35385, Germany

Marburg D-35039, Germany

Wiesbaden D-65191, Germany

Additional Information

Starting date: March 2005
Last updated: December 21, 2007

Page last updated: August 23, 2015

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