STudy to vAlidate telemetRic ECG Systems for firsT Dose Administration of Fingolimod (START) (START)
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|ClinicalTrials.gov Identifier: NCT01585298|
Recruitment Status : Completed
First Posted : April 25, 2012
Results First Posted : September 23, 2019
Last Update Posted : September 23, 2019
|Condition or disease||Intervention/treatment||Phase|
|Multiple Sclerosis||Drug: FTY720||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||6998 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||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|
|Actual Study Start Date :||April 29, 2012|
|Actual Primary Completion Date :||December 12, 2016|
|Actual Study Completion Date :||December 12, 2016|
Fingolimod 0.5 mg by mouth once daily for 7 days.
Other Name: 0.5 mg gelatin capsules
- Participants With 2nd or 3rd Degree Atrioventricular (AV) Block [ Time Frame: baseline, during 6 hour monitoring post first dose observation ]AV Blocks/Heart block is an abnormal heart rhythm where the heart beats too slowly; the electrical signals that tell the heart to contract are partially intermittent (Type 2:1) or slowed (1st and 2nd degree) or blocked (3rd degree) between the upper chambers (atria) and the lower chambers (ventricles). In 2nd degree AV Blocks, electrical impulses are intermittent (type 2:1) or delayed w/ each subsequent heartbeat (Mobitz type I) until a beat fails to reach the ventricles entirely. This type of block often is physiologic and observed in a highly relaxed state & during sleep. In 2nd degree AV Blocks type II, the atria electrical impulses are unable to reach the ventricles, a more serious condition. In 3rd degree AV Blocks (complete heart block), none of the electrical impulses reach either the atria or the ventricles. Patients can experience simultaneously both types of 2nd or 3rd degree AV Blocks without any symptoms.
- Number of Patients With Heart Rate Below 45 Beats Per Minute (BPM) [ Time Frame: baseline during 6 hour monitoring post dose ]Number of patients with heart rate below 45 beats bpm in ECG during first dose observation
- Number of Participants With Prolonged QTc Interval (Friderica) [ Time Frame: baseline post-dose ]
Number of patients with conduction abnormalities such as QT prolongation, first degree AV block during treatment initiation.
The QT interval is a period between the activation and the regeneration of ventricular contraction. A prolonged QT interval can be a potential marker of cardiac arrhythmias.
Two patients of the safety analysis set discontinued the study without having received treatment, but safety information was collected on these two patients.
- Number of Participants With Bradyarrhythmic Electrocardiogram (ECG) Events [ Time Frame: up to day 7 ]The number of participants with bradyarrhythmic electrocardiogram (ECG) events was assessed. Bradyarrhythmic ECG events are defined as QTc Fridericia time > 450 ms for males and > 470 ms for females.
- Number of Patients With Cardiac Adverse Events [ Time Frame: 7 days ]The number of participants with the occurrence of subsequent cardiac adverse events (AEs) and serious cardiac AEs during study was assessed. Cardiac events were defined as the following Medical Dictionary for Regulatory Activities (MedDRA) preferred terms: angina pectoris, chest discomfort, dizziness, dyspnoea, dyspnoea exertional, fatigue, palpitations, syncope, vertigo, vertigo positional and vision blurred.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01585298
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|Study Director:||Novartis Pharmaceuticals||Novartis Pharmaceuticals|