Back to resultsStudy Evaluating Mitoxantrone in Multiple Sclerosis
Primary Purpose
Secondary Progressive Multiple Sclerosis
Status
Terminated
Phase
Phase 3
Locations
Germany
Study Type
Interventional
Intervention
Mitoxantrone
Sponsored by
About this trial
This is an interventional treatment trial for Secondary Progressive Multiple Sclerosis focused on measuring Multiple Sclerosis
Eligibility 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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
1
2
3
Arm Description
1st group: 12 mg Mitoxantrone/m²
2nd group: 9mg Mitoxantrone/m²
3rd group: 5mg Mitoxantrone/m²
Outcomes
Primary Outcome Measures
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 Measures
derivations of EDSS and relapses; MRI (baseline, 2 years)
Full Information
NCT ID
NCT00146159
First Posted
September 1, 2005
Last Updated
December 21, 2007
Sponsor
Wyeth is now a wholly owned subsidiary of Pfizer
1. Study Identification
Unique Protocol Identification Number
NCT00146159
Brief Title
Study Evaluating Mitoxantrone in Multiple Sclerosis
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 Type
Interventional
2. Study Status
Record Verification Date
December 2007
Overall Recruitment Status
Terminated
Study Start Date
March 2005 (undefined)
Primary Completion Date
September 2007 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Wyeth is now a wholly owned subsidiary of Pfizer
4. Oversight
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Secondary Progressive Multiple Sclerosis
Keywords
Multiple Sclerosis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
336 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
1st group: 12 mg Mitoxantrone/m²
Arm Title
2
Arm Type
Experimental
Arm Description
2nd group: 9mg Mitoxantrone/m²
Arm Title
3
Arm Type
Experimental
Arm Description
3rd group: 5mg Mitoxantrone/m²
Intervention Type
Drug
Intervention Name(s)
Mitoxantrone
Intervention Description
dosage
Primary Outcome Measure Information:
Title
3 clinical measures combined in a multivariate analysis: confirmed Expanded Disability Status Scale(EDSS)
Time Frame
3 years
Title
deterioration, change of ambulation index, time to first relapse requiring corticoid treatment
Time Frame
3 years
Secondary Outcome Measure Information:
Title
derivations of EDSS and relapses; MRI (baseline, 2 years)
Time Frame
3 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Monitor
Organizational Affiliation
Wyeth is now a wholly owned subsidiary of Pfizer
Official's Role
Study Director
Facility Information:
City
Berg
ZIP/Postal Code
D-82335
Country
Germany
City
Berlin
ZIP/Postal Code
D-13347
Country
Germany
City
Düsseldorf
ZIP/Postal Code
D-40225
Country
Germany
City
Düsseldorf
ZIP/Postal Code
D-40479
Country
Germany
City
Gießen
ZIP/Postal Code
D-35385
Country
Germany
City
Marburg
ZIP/Postal Code
D-35039
Country
Germany
City
Wiesbaden
ZIP/Postal Code
D-65191
Country
Germany
12. IPD Sharing Statement
Learn more about this trial
Study Evaluating Mitoxantrone in Multiple Sclerosis
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