Study Evaluating Mitoxantrone in Multiple Sclerosis

Secondary Progressive Multiple Sclerosis Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00146159
• Other study ID #: 0906E-100925
• Status: Terminated
• Phase: Phase 3
• First received: September 1, 2005
• Last updated: December 21, 2007
• Start date: March 2005

Study information

• Verified date: December 2007
• Source: Wyeth is now a wholly owned subsidiary of Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 336
• Est. primary completion date: September 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Multiple Sclerosis
• Multiple Sclerosis, Chronic Progressive
• Sclerosis
• Secondary Progressive Multiple Sclerosis

Intervention

Drug:
• Mitoxantrone
dosage

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Wyeth is now a wholly owned subsidiary of Pfizer

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	3 clinical measures combined in a multivariate analysis: confirmed Expanded Disability Status Scale(EDSS)		3 years	No
Primary	deterioration, change of ambulation index, time to first relapse requiring corticoid treatment		3 years	No
Secondary	derivations of EDSS and relapses; MRI (baseline, 2 years)		3 years	No