Study Evaluating Mitoxantrone in Multiple Sclerosis

Phase 3

Terminated

• Conditions: Secondary Progressive Multiple Sclerosis
• Interventions: Drug: Mitoxantrone

• Registration Number: NCT00146159
• Lead Sponsor: Wyeth is now a wholly owned subsidiary of Pfizer

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2005-03
• Study First Submitted: 2005-09-01
• Study First Submitted QC: 2005-09-01
• Study First Posted: 2005-09-05
• Primary Completion: 2007-09
• Status Verified: 2007-12
• Last Update Submitted: 2007-12-21
• Last Update Posted: 2007-12-28

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 336

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Mitoxantrone	1st group: 12 mg Mitoxantrone/m²
3	Mitoxantrone	3rd group: 5mg Mitoxantrone/m²
2	Mitoxantrone	2nd group: 9mg Mitoxantrone/m²

Primary Outcome Measures

Name	Time	Method
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

Secondary Outcome Measures

Name	Time	Method
derivations of EDSS and relapses; MRI (baseline, 2 years)	3 years