A study to explore heart function during first dose administration of
A 1-week, open-label, multi-center study to explore conduction abnormalities during first dose administration of fingolimod in patients with relapsing-remitting multiple sclerosis (START)
What it found
We found no results in the registry or in papers.
What was tested
Treatment tested
What it measured
Main measures
To evaluate the incidence of patients with bradycardia (heart rate < 45 beats per min) and bradyarrhythmic ECG events during 6-hour monitoring period as measured by heart rate and second and third-degree AV blocks after treatment initiation of fingolimod 0.5 mg.
Other measures (1)
• To evaluate the incidence of patients with other conduction abnormalities (such as QT prolongation, first degree AV block) after treatment initiation of fingolimod 0.5 mg.
Who could take part
Relapsing MS
Show the full criteria
Inclusion criteria
Inclusion: 1. Written informed consent from patients capable of giving or withholding full informed consent must be obtained before any assessment is performed. Exclusion: 1. Known immunodeficiency syndrome.
Exclusion criteria
Not separately supplied in the registry.
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
To evaluate the incidence of patients with bradycardia (heart rate < 45 beats per min) and bradyarrhythmic ECG events during 6-hour monitoring period as measured by heart rate and second and third-degree AV blocks after treatment initiation of fingolimod 0.5 mg.
Papers
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History
Started
Apr 2012