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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
Information provided by:
Wyeth is now a wholly owned subsidiary of Pfizer

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.

Condition or disease Intervention/treatment Phase
Secondary Progressive Multiple Sclerosis Drug: Mitoxantrone Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 336 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : March 2005
Primary Completion Date : September 2007

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: 1
1st group: 12 mg Mitoxantrone/m²
Drug: Mitoxantrone
Experimental: 2
2nd group: 9mg Mitoxantrone/m²
Drug: Mitoxantrone
Experimental: 3
3rd group: 5mg Mitoxantrone/m²
Drug: Mitoxantrone

Primary Outcome Measures :
  1. 3 clinical measures combined in a multivariate analysis: confirmed Expanded Disability Status Scale(EDSS) [ Time Frame: 3 years ]
  2. deterioration, change of ambulation index, time to first relapse requiring corticoid treatment [ Time Frame: 3 years ]

Secondary Outcome Measures :
  1. derivations of EDSS and relapses; MRI (baseline, 2 years) [ Time Frame: 3 years ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00146159

Berg, Germany, D-82335
Berlin, Germany, D-13347
Düsseldorf, Germany, D-40225
Düsseldorf, Germany, D-40479
Gießen, Germany, D-35385
Marburg, Germany, D-35039
Wiesbaden, Germany, D-65191
Sponsors and Collaborators
Wyeth is now a wholly owned subsidiary of Pfizer
Study Director: Medical Monitor Wyeth is now a wholly owned subsidiary of Pfizer

Responsible Party: Wyeth (Clinical Trials Registry Specialist), Wyeth
ClinicalTrials.gov Identifier: NCT00146159     History of Changes
Other Study ID Numbers: 0906E-100925
First Posted: September 5, 2005    Key Record Dates
Last Update Posted: December 28, 2007
Last Verified: December 2007

Keywords provided by Wyeth is now a wholly owned subsidiary of Pfizer:
Multiple Sclerosis

Additional relevant MeSH terms:
Multiple Sclerosis
Neoplasm Metastasis
Multiple Sclerosis, Chronic Progressive
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Neoplastic Processes
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Antineoplastic Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action