Study Evaluating Mitoxantrone in Multiple Sclerosis

Sponsor

Wyeth is now a wholly owned subsidiary of Pfizer (Industry)

Overall Status

Terminated

CT.gov ID

NCT00146159

Collaborator

(none)

336

Enrollment

Locations

Arms

Patients Per Site

Study Details

Study Description

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 Design

Study Type:

Interventional

Anticipated 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 :

Mar 1, 2005

Actual Primary Completion Date :

Sep 1, 2007

Arms and Interventions

Arm	Intervention/Treatment
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

Arm

Intervention/Treatment

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

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

derivations of EDSS and relapses; MRI (baseline, 2 years) [3 years]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 55 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	City	Country	Postal Code
1	Berg	Germany	D-82335
2	Berlin	Germany	D-13347
3	Düsseldorf	Germany	D-40225
4	Düsseldorf	Germany	D-40479
5	Gießen	Germany	D-35385
6	Marburg	Germany	D-35039
7	Wiesbaden	Germany	D-65191