Prospective, Open-label Tolerability and Safety Monitoring Study of Novantrone in a Selected Cohort of Multiple Sclerosis Patients

Completed

Conditions studied: Multiple Sclerosis

In brief

The overall objective of this study is to collect data relevant to the tolerability of Novantrone® therapy in patients with multiple sclerosis (MS) using dosing and monitoring recommendations specified in the package insert.

Key facts

Study ID

NCT00262314

Run by

EMD Serono

People needed

509

Starts

2000-10-01

Expected to finish

2008-09-01

Last updated by the study team

2013-11-14

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• To be eligible for inclusion into this study, the subjects must fulfill all of the following criteria:
• Platelet count >100,000 cells/µL
• Granulocyte count > 2000 cells/µL
• Age 18-65 years
• Negative pregnancy test for female patients who are biologically capable of becoming pregnant, even if they are taking birth control
• For patients of reproductive age, agreement to practice effective contraception throughout the study and for 6 months following the last administration of Novantrone®
• Signed Inform Consent.

You may not qualify if…

• To be eligible for inclusion in this study the subjects must not meet any of the following criteria:
• Presence of cardiac risk factors:
• History of congestive heart failure
• LVEF < 50% determined by echocardiography or MUGA
• Previous treatment with Novantrone®, other anthracenediones, or anthracyclines
• Prior mediastinal radiotherapy or total lymphoidal irradiation
• AST, ALT, bilirubin > 2x upper limits of normal
• Severe untreated infection (including current urinary tract infection)
• Nursing or pregnant women)

Where it is running

• Registrat Inc — Lexington, Kentucky, United States

Full record on ClinicalTrials.gov

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