Study Evaluating Mitoxantrone in Multiple Sclerosis

Wyeth

Status and phase: Terminated; Phase 3

Conditions: Secondary Progressive Multiple Sclerosis

Treatments: Drug: Mitoxantrone

Study type: Interventional

Funder types: Industry

Identifiers

NCT00146159

0906E-100925

Details and patient eligibility

About

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.

Enrollment: 336 estimated patients

Sex: All

Ages: 18 to 55 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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336 participants in 3 patient groups

1

Experimental group

Description:

1st group: 12 mg Mitoxantrone/m²

Treatment:

Drug: Mitoxantrone

2

Experimental group

Description:

2nd group: 9mg Mitoxantrone/m²

Treatment:

Drug: Mitoxantrone

3

Experimental group

Description:

3rd group: 5mg Mitoxantrone/m²

Treatment:

Drug: Mitoxantrone