Study Evaluating Mitoxantrone in Multiple Sclerosis

Phase 3TerminatedNCT00146159

Wyeth is now a wholly owned subsidiary of Pfizer336 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

336

Conditions

Secondary Progressive Multiple Sclerosis

Interventions

MitoxantroneDRUG

dosage

Eligibility

Sex: ALLMin age: 18 YearsMax age: 55 Years

Medical Language ↔ Plain English

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 (7)

Unnamed facility

Berg, Germany

Unnamed facility

Berlin, Germany

Unnamed facility

Düsseldorf, Germany

Unnamed facility

Düsseldorf, Germany

Unnamed facility

Outcomes

Primary Outcomes

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

Time frame: 3 years

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

Time frame: 3 years

Secondary Outcomes

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

Time frame: 3 years

Data from ClinicalTrials.gov

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