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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
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

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

Condition or disease Intervention/treatment Phase
Multiple Sclerosis Drug: FTY720 Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 6998 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Fingolimod
Fingolimod 0.5 mg by mouth once daily for 7 days.
Drug: FTY720
Other Name: 0.5 mg gelatin capsules




Primary Outcome Measures :
  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 Outcome Measures :
  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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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).

Information from the National Library of Medicine

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


  Show 259 Study Locations
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
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Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01585298     History of Changes
Other Study ID Numbers: CFTY720DDE17
First Posted: April 25, 2012    Key Record Dates
Results First Posted: September 23, 2019
Last Update Posted: September 23, 2019
Last Verified: August 2019
Keywords provided by Novartis ( Novartis Pharmaceuticals ):
Multiple Sclerosis
MS
Fingolimod
Gilenya
ECG
Bradyarrythmia
conduction abnormalities
first dose observation
Additional relevant MeSH terms:
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Multiple Sclerosis
Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Fingolimod Hydrochloride
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs