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Study Evaluating Mitoxantrone in Multiple Sclerosis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00146159
Recruitment Status : Terminated
First Posted : September 5, 2005
Last Update Posted : December 28, 2007
Sponsor:
Information provided by:
Wyeth is now a wholly owned subsidiary of Pfizer

Tracking Information
First Submitted Date  ICMJE September 1, 2005
First Posted Date  ICMJE September 5, 2005
Last Update Posted Date December 28, 2007
Study Start Date  ICMJE March 2005
Actual Primary Completion Date September 2007   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 21, 2007)
  • 3 clinical measures combined in a multivariate analysis: confirmed Expanded Disability Status Scale(EDSS) [ Time Frame: 3 years ]
  • deterioration, change of ambulation index, time to first relapse requiring corticoid treatment [ Time Frame: 3 years ]
Original Primary Outcome Measures  ICMJE
 (submitted: September 1, 2005)
  • 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
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 21, 2007)		 derivations of EDSS and relapses; MRI (baseline, 2 years) [ Time Frame: 3 years ]
Original Secondary Outcome Measures  ICMJE
 (submitted: September 1, 2005)		 derivations of EDSS and relapses; MRI (baseline, 2 years)
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study Evaluating Mitoxantrone in Multiple Sclerosis
Official Title  ICMJE 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
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Secondary Progressive Multiple Sclerosis
Intervention  ICMJE Drug: Mitoxantrone
dosage
Study Arms  ICMJE
  • 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
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Estimated Enrollment  ICMJE
 (submitted: September 1, 2005)		 336
Original Enrollment  ICMJE Same as current
Study Completion Date  ICMJE Not Provided
Actual Primary Completion Date September 2007   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00146159
Other Study ID Numbers  ICMJE 0906E-100925
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Wyeth (Clinical Trials Registry Specialist), Wyeth
Original Responsible Party Not Provided
Current Study Sponsor  ICMJE Wyeth is now a wholly owned subsidiary of Pfizer
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Medical Monitor Wyeth is now a wholly owned subsidiary of Pfizer
PRS Account Wyeth is now a wholly owned subsidiary of Pfizer
Verification Date December 2007

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