Status:
COMPLETED
Prospective, Open-label Tolerability and Safety Monitoring Study of Novantrone in a Selected Cohort of Multiple Sclerosis Patients
Lead Sponsor:
EMD Serono
Conditions:
Multiple Sclerosis
Eligibility:
All Genders
18-65 years
Brief Summary
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 specifie...
Detailed Description
This phase IV, multicenter, prospective, open-label tolerability and safety monitoring study will enroll a select cohort of 500 multiple sclerosis patients receiving commercially available Novantrone®...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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)
Key Trial Info
Start Date :
October 1 2000
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
September 1 2008
Estimated Enrollment :
509 Patients enrolled
Trial Details
Trial ID
NCT00262314
Start Date
October 1 2000
End Date
September 1 2008
Last Update
November 14 2013
Active Locations (1)
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1
Registrat Inc
Lexington, Kentucky, United States, 40504-3276