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ABOUT THIS STUDY
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.
FOR MORE INFORMATION
Contact a representative by phone, email, or visiting the study website. Please see the references below:
By phone
Pfizer Clinical Trials Contact Center
1-800-718-1021
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
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
- Berg,
- Berlin,
- Düsseldorf,
- Düsseldorf,
- Gießen,
- Marburg,
- 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 |
| |||
| 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 | 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:
Exclusion Criteria:
| |||
| Sex/Gender ICMJE |
| |||
| 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 |
| |||
| 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 | ||||