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Study Evaluating Mitoxantrone in Multiple Sclerosis

This study has been terminated.
Sponsor:
Information provided by:
Wyeth is now a wholly owned subsidiary of Pfizer
ClinicalTrials.gov Identifier:
NCT00146159
First received: September 1, 2005
Last updated: December 21, 2007
Last verified: December 2007
History of Changes

September 1, 2005
December 21, 2007
March 2005
September 2007   (final data collection date for primary outcome measure)
  • 3 clinical measures combined in a multivariate analysis: confirmed Expanded Disability Status Scale(EDSS) [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  • deterioration, change of ambulation index, time to first relapse requiring corticoid treatment [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  • 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
Complete list of historical versions of study NCT00146159 on ClinicalTrials.gov Archive Site
derivations of EDSS and relapses; MRI (baseline, 2 years) [ Time Frame: 3 years ] [ Designated as safety issue: No ]
derivations of EDSS and relapses; MRI (baseline, 2 years)
Not Provided
Not Provided
 
Study Evaluating Mitoxantrone in Multiple Sclerosis
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.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Secondary Progressive Multiple Sclerosis
Drug: Mitoxantrone
dosage
  • Experimental: 1
    1st group: 12 mg Mitoxantrone/m²
    Intervention: Drug: Mitoxantrone
  • Experimental: 2
    2nd group: 9mg Mitoxantrone/m²
    Intervention: Drug: Mitoxantrone
  • Experimental: 3
    3rd group: 5mg Mitoxantrone/m²
    Intervention: Drug: Mitoxantrone
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
336
Not Provided
September 2007   (final data collection date for primary outcome measure)

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
Both
18 Years to 55 Years
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT00146159
0906E-100925
Not Provided
Wyeth (Clinical Trials Registry Specialist), Wyeth
Wyeth is now a wholly owned subsidiary of Pfizer
Not Provided
Study Director: Medical Monitor Wyeth is now a wholly owned subsidiary of Pfizer
Wyeth is now a wholly owned subsidiary of Pfizer
December 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP