MedDataX Logo

Study Evaluating Mitoxantrone in Multiple Sclerosis

NCT ID: NCT00146159

Last Updated: 2007-12-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

336 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-03-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Secondary Progressive Multiple Sclerosis

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Multiple Sclerosis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

1

1st group: 12 mg Mitoxantrone/m²

Group Type EXPERIMENTAL

Mitoxantrone

Intervention Type DRUG

dosage

2

2nd group: 9mg Mitoxantrone/m²

Group Type EXPERIMENTAL

Mitoxantrone

Intervention Type DRUG

dosage

3

3rd group: 5mg Mitoxantrone/m²

Group Type EXPERIMENTAL

Mitoxantrone

Intervention Type DRUG

dosage

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Mitoxantrone

dosage

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Wyeth is now a wholly owned subsidiary of Pfizer

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Wyeth

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Medical Monitor

Role: STUDY_DIRECTOR

Wyeth is now a wholly owned subsidiary of Pfizer

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Berg, , Germany

Site Status

Berlin, , Germany

Site Status

Düsseldorf, , Germany

Site Status

Düsseldorf, , Germany

Site Status

Giessen, , Germany

Site Status

Marburg, , Germany

Site Status

Wiesbaden, , Germany

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Germany

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

0906E-100925

Identifier Type: -

Identifier Source: org_study_id