NCT00262314

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 509 (actual)
• Sponsor: EMD Serono · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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 specified in the package insert.

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®. The patients will be assessed every 3 months during treatment followed by annual assessment for a total of five (5) years. The select cohort of MS patients enrolled will have secondary (chronic) progressive, progressive relapsing, or worsening relapsing-remitting disease (i.e., patients whose neurological status is significantly abnormal between relapses). 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.

Conditions

• Multiple Sclerosis

Timeline

• Start date: 2000-10-01
• Primary completion: 2008-01-01
• Completion: 2008-09-01
• First posted: 2005-12-06
• Last updated: 2013-11-14
• Results posted: 2010-06-23

Locations

1 site across 1 country: United States