Study Evaluating Mitoxantrone in Multiple Sclerosis

NCT00146159

Last updated date
Study Location
Berg, , D-82335, Germany
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Secondary Progressive Multiple Sclerosis
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-55 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Secondary progressive MS in an active stage

- EDSS between 3 and 6

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- Benign or primary progressive MS


- Patients with cardiac risk factors


- Patients who have already received mitoxantrone

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Secondary Progressive Multiple SclerosisStudy Evaluating Mitoxantrone in Multiple Sclerosis
NCT00146159
  1. Berg,
  2. Berlin,
  3. Düsseldorf,
  4. Düsseldorf,
  5. Gießen,
  6. Marburg,
  7. Wiesbaden,
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
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
Responsible Party Wyeth (Clinical Trials Registry Specialist), Wyeth
Study Sponsor  ICMJE Wyeth is now a wholly owned subsidiary of Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Medical MonitorWyeth 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