STudy to vAlidate telemetRic ECG Systems for firsT Dose Administration of Fingolimod (START)

Phase 4

Completed

• Conditions: Multiple Sclerosis
• Interventions: Drug: FTY720

• Registration Number: NCT01585298
• Lead Sponsor: Novartis Pharmaceuticals

Brief Summary

This study evaluated bradycardiac events during first dose observation of fingolimod in MS patients.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-04-23
• Study First Submitted QC: 2012-04-24
• Study First Posted: 2012-04-25
• Study Start: 2012-04-29
• Primary Completion: 2016-12-12
• Study Completion: 2016-12-12
• Results First Submitted: 2017-12-07
• Status Verified: 2019-08
• Results First Submitted QC: 2019-08-21
• Last Update Submitted: 2019-08-21
• Results First Posted: 2019-09-23
• Last Update Posted: 2019-09-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 6998

Inclusion Criteria

• Subjects with relapsing remitting MS.
• Patients with highly active disease despite a full and adequate course of treatment with at least one disease modifying therapy.
• Patients who had been previously on 2nd line therapies. It was understood that these patients satisfied the above mentioned criteria listed under a. in the past.

This also included patients, who were previously treated with fingolimod (regardless of whether or not they had already been treated within the START study) but discontinued treatment due to medical reasons.

• or patients with rapidly evolving severe RRMS (e.g. > 2 relapses with disease progression in one year and > 1 Gd-enhancing lesion or with a significant increase in T2 lesions compared to a recent MRI).

Key

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Exclusion Criteria

• immunocompromised patients
• active infections
• pregnant or nursing women, women of childbearing potential unless using 2 reliable forms of contraception
• presence of malignancy (other than localized basal cell carcinoma of the skin).

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Fingolimod	FTY720	Fingolimod 0.5 mg by mouth once daily for 7 days.

Primary Outcome Measures

Name	Time	Method
Number of Patients With Heart Rate Below 45 Beats Per Minute (BPM)	baseline during 6 hour monitoring post dose	Number of patients with heart rate below 45 beats bpm in ECG during first dose observation
Participants With 2nd or 3rd Degree Atrioventricular (AV) Block	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.

Secondary Outcome Measures

Name	Time	Method
Number of Participants With Prolonged QTc Interval (Friderica)	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	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	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.

Trial Locations

Locations (1)

Novartis Investigative Site; 🇩🇪 Öhringen, Germany