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Study Evaluating Mitoxantrone in Multiple Sclerosis

This study has been terminated.
Sponsor:
Information provided by:
Wyeth is now a wholly owned subsidiary of Pfizer
ClinicalTrials.gov Identifier:
NCT00146159
First received: September 1, 2005
Last updated: December 21, 2007
Last verified: December 2007
History of Changes
  Purpose

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:

U.S. FDA Resources

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
dosage
Experimental: 2
2nd group: 9mg Mitoxantrone/m²
 Drug: Mitoxantrone
dosage
Experimental: 3
3rd group: 5mg Mitoxantrone/m²
 Drug: Mitoxantrone
dosage

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00146159

Locations
Germany
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
Investigators
Study Director: Medical Monitor Wyeth is now a wholly owned subsidiary of Pfizer
  More Information

No publications provided

Responsible Party: Wyeth (Clinical Trials Registry Specialist), Wyeth
ClinicalTrials.gov 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
Sclerosis
Multiple Sclerosis, Chronic Progressive
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Pathologic Processes
 Mitoxantrone
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Central Nervous System Agents

ClinicalTrials.gov processed this record on May 21, 2013