Study Evaluating Mitoxantrone in Multiple Sclerosis

December 21, 2007 updated by: Wyeth is now a wholly owned subsidiary of Pfizer

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

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 Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

336

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Berg, Germany, D-82335
      • Berlin, Germany, D-13347
      • Düsseldorf, Germany, D-40225
      • Düsseldorf, Germany, D-40479
      • Gießen, Germany, D-35385
      • Marburg, Germany, D-35039
      • Wiesbaden, Germany, D-65191

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
1st group: 12 mg Mitoxantrone/m²
Drug: Mitoxantrone
dosage
Experimental: 2
2nd group: 9mg Mitoxantrone/m²
Drug: Mitoxantrone
dosage
Experimental: 3
3rd group: 5mg Mitoxantrone/m²
Drug: Mitoxantrone
dosage

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
3 clinical measures combined in a multivariate analysis: confirmed Expanded Disability Status Scale(EDSS)
Time Frame: 3 years
3 years
deterioration, change of ambulation index, time to first relapse requiring corticoid treatment
Time Frame: 3 years
3 years

Secondary Outcome Measures

Outcome Measure
Time Frame
derivations of EDSS and relapses; MRI (baseline, 2 years)
Time Frame: 3 years
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Wyeth is now a wholly owned subsidiary of Pfizer

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2005

Primary Completion (Actual)

September 1, 2007

Study Registration Dates

First Submitted

September 1, 2005

First Submitted That Met QC Criteria

September 1, 2005

First Posted (Estimate)

September 5, 2005

Study Record Updates

Last Update Posted (Estimate)

December 28, 2007

Last Update Submitted That Met QC Criteria

December 21, 2007

Last Verified

December 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0906E-100925

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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