Study Evaluating Mitoxantrone in Multiple Sclerosis

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

Status

Terminated

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00146159

Enrollment

336

Registered

2005-09-05

Start date

2005-03-31

Completion date

Unknown

Last updated

2007-12-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Secondary Progressive Multiple Sclerosis

Keywords

Multiple Sclerosis

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.

Interventions

DRUGMitoxantrone

dosage

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 55 Years

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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
derivations of EDSS and relapses; MRI (baseline, 2 years)	3 years

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026