Study Evaluating Mitoxantrone in Multiple Sclerosis

This study has been terminated.
Information provided by:
Wyeth is now a wholly owned subsidiary of Pfizer Identifier:
First received: September 1, 2005
Last updated: December 21, 2007
Last verified: December 2007
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 Intervention Phase
Secondary Progressive Multiple Sclerosis
Drug: Mitoxantrone
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:

Further study details as provided by Wyeth is now a wholly owned subsidiary of Pfizer:

Primary Outcome Measures:
  • 3 clinical measures combined in a multivariate analysis: confirmed Expanded Disability Status Scale(EDSS) [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  • deterioration, change of ambulation index, time to first relapse requiring corticoid treatment [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • derivations of EDSS and relapses; MRI (baseline, 2 years) [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 336
Study Start Date: March 2005
Primary Completion Date: September 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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


Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: 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
  More Information

Responsible Party: Wyeth (Clinical Trials Registry Specialist), Wyeth Identifier: NCT00146159     History of Changes
Other Study ID Numbers: 0906E-100925 
Study First Received: September 1, 2005
Last Updated: December 21, 2007
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

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

Additional relevant MeSH terms:
Multiple Sclerosis
Multiple Sclerosis, Chronic Progressive
Autoimmune Diseases
Autoimmune Diseases of the Nervous System
Demyelinating Autoimmune Diseases, CNS
Demyelinating Diseases
Immune System Diseases
Nervous System Diseases
Pathologic Processes
Antineoplastic Agents
Central Nervous System Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses
Topoisomerase II Inhibitors
Topoisomerase Inhibitors processed this record on May 05, 2016