Study Evaluating Mitoxantrone in Multiple Sclerosis

Sponsor
Wyeth is now a wholly owned subsidiary of Pfizer (Industry)
Overall Status
Terminated
CT.gov ID
NCT00146159
Collaborator
(none)
336
Enrollment
7
Locations
3
Arms
48
Patients Per Site

Study Details

Study Description

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.

Condition or DiseaseIntervention/TreatmentPhase
Phase 3

Study Design

Study Type:
Interventional
Anticipated Enrollment :
336 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
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 Start Date :
Mar 1, 2005
Actual Primary Completion Date :
Sep 1, 2007

Arms and Interventions

ArmIntervention/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

Outcome Measures

Primary Outcome Measures

  1. 3 clinical measures combined in a multivariate analysis: confirmed Expanded Disability Status Scale(EDSS) [3 years]

  2. deterioration, change of ambulation index, time to first relapse requiring corticoid treatment [3 years]

Secondary Outcome Measures

  1. derivations of EDSS and relapses; MRI (baseline, 2 years) [3 years]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 55 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

SiteCityStateCountryPostal Code
1BergGermanyD-82335
2BerlinGermanyD-13347
3DüsseldorfGermanyD-40225
4DüsseldorfGermanyD-40479
5GießenGermanyD-35385
6MarburgGermanyD-35039
7WiesbadenGermanyD-65191

Sponsors and Collaborators

  • Wyeth is now a wholly owned subsidiary of Pfizer

Investigators

  • Study Director: Medical Monitor, Wyeth is now a wholly owned subsidiary of Pfizer

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
, ,
ClinicalTrials.gov Identifier:
NCT00146159
Other Study ID Numbers:
  • 0906E-100925
First Posted:
Sep 5, 2005
Last Update Posted:
Dec 28, 2007
Last Verified:
Dec 1, 2007

Study Results

No Results Posted as of Dec 28, 2007