NCT01704183

Effect of Fingolimod on the Cardiac Autonomic Regulation in Patients With Multiple Sclerosis

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 27 (actual)
• Sponsor: Kuopio University Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to study the effect of fingolimod on cardiac autonomic regulation in patients with relapse-remitting multiple sclerosis. This will be done by measuring heart rate variability from the 24-hour Holter recording and myocardial ventricular repolarisation patterns from the 12-lead electrocardiogram tracings. The fingolimod treatment is prescribed according to the accepted drug label.

Detailed description

The study will include 30 relapse-remitting multiple sclerosis patients. Assessments of heart rate variability and myocardial ventricular repolarisation pattern will be done 1) before fingolimod, 2) first day of fingolimod 3) after 3 months use and 4) after 12 months use of fingolimod.

Conditions

• Relapse-remitting Multiple Sclerosis

Timeline

• Start date: 2012-12-01
• Primary completion: 2014-03-01
• Completion: 2014-03-01
• First posted: 2012-10-11
• Last updated: 2014-05-08

Locations

2 sites across 1 country: Finland