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Completed

NCT Number: NCT01585298

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

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

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Key information

Conditions

Multiple Sclerosis Autoimmune Diseases Autoimmune Diseases of the Nervous System Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Immune System Diseases Nervous System Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Novartis Investigative Site, Ostfildern, Baden-Wurttemberg, Germany

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

FTY720

Drug

Other names: 0.5 mg gelatin capsules

Primary outcomes

  1. 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.

  2. 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

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Official study 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

Acronym: START

Important dates

Study start
2012
Primary completion
2016
Study completion
2016
First posted
Apr 25, 2012
Registry last updated
Sep 23, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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