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

Phase 4CompletedNCT01585298

Novartis Pharmaceuticals6,998 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

6,998

Conditions

Multiple Sclerosis

Interventions

FTY720DRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Key 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 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).

Locations (258)

Outcomes

Primary Outcomes

Participants With 2nd or 3rd Degree Atrioventricular (AV) Block

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.

Time frame: baseline, during 6 hour monitoring post first dose observation

Number of Patients With Heart Rate Below 45 Beats Per Minute (BPM)

Number of patients with heart rate below 45 beats bpm in ECG during first dose observation

Time frame: baseline during 6 hour monitoring post dose

Secondary Outcomes

Number of Participants With Prolonged QTc Interval (Friderica)

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.

Time frame: baseline post-dose

Number of Participants With Bradyarrhythmic Electrocardiogram (ECG) Events

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.

Data from ClinicalTrials.gov

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Novartis Investigative Site

Ostfildern, Baden-Wurttemberg, Germany

Novartis Investigative Site

Munich, Bavaria, Germany

Novartis Investigative Site

Altenholz-Stift, Germany, Germany

Novartis Investigative Site

Cologne, North Rhine-Westphalia, Germany

Novartis Investigative Site

Flensburg, Schleswig-Holstein, Germany

Novartis Investigative Site

Aachen, Germany

Novartis Investigative Site

Aachen, Germany

Novartis Investigative Site

Aalen, Germany

Novartis Investigative Site

Aalen-Wasseralfingen, Germany

Novartis Investigative Site

Abensberg, Germany

...and 248 more locations