Study Evaluating Mitoxantrone in Multiple Sclerosis

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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

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

Trial contacts and locations

7

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Data sourced from clinicaltrials.gov

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