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Study Evaluating Mitoxantrone in Multiple Sclerosis

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NCT00146159

Last updated on August 9, 2018
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FOR MORE INFORMATION
Study Location
Berg, , D-82335 Germany
See other locations
Contact
1-800-718-1021
[email protected]
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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

NCT00146159
Pfizer
Terminated
Study Evaluating Mitoxantrone in Multiple Sclerosis

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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
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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
Sexes Eligible for Study: All
18 Years to 55 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
 
NCT00146159
0906E-100925
Not Provided
Not Provided
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

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

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Pfizer Clinical Trials Contact Center

1-800-718-1021

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Contact

[email protected]



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