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

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Novartis
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01585298
First received: April 23, 2012
Last updated: July 8, 2014
Last verified: July 2014
  Purpose

Study to evaluate bradycardiac events during first dose observation of fingolimod in MS patients


Condition Intervention Phase
Multiple Sclerosis
Drug: FTY720
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • Number of patients with bradyarrhythmic events [ Time Frame: baseline ] [ Designated as safety issue: Yes ]
    number of patients with bradyarrhythmia (2nd or 3rd AV block or heart rate below 40 beats per minute) in ECG during first dose observation


Secondary Outcome Measures:
  • Number of patients with other conduction abnormalities in ECG [ Time Frame: baseline ] [ Designated as safety issue: Yes ]
    number of patients with conduction abnormalities such as QT prolongation, first degree AV block during treatment initiation

  • Number of patients with cardiac adverse events [ Time Frame: 7 days ] [ Designated as safety issue: Yes ]
    occurrence of subsequent cardiac AEs and serious cardiac AEs during study


Estimated Enrollment: 7000
Study Start Date: June 2012
Estimated Study Completion Date: November 2015
Estimated Primary Completion Date: November 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Fingolimod Drug: FTY720

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subjects with relapsing remitting MS with high disease activity despite treatment with a disease modifying therapy (> 1 relapse in the previous year, > 9 hyperintense T2 lesions or > 1 Gd-enhancing lesion or "non-responding" which could be defined as unchanged or increased relapse rate or ongoing severe relapses compared to previous year) 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).

Exclusion Criteria:

  • immunocompromised patients
  • active infections
  • pregnant or nursing women, women of childbearing potential unless using 2 reliable forms of contraception

Other protocol-defined inclusion/exclusion criteria may apply

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01585298

Contacts
Contact: Novartis Pharmaceuticals +41613241111
Contact: Novartis Pharmaceuticals

  Show 263 Study Locations
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

No publications provided

Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT01585298     History of Changes
Other Study ID Numbers: CFTY720DDE17
Study First Received: April 23, 2012
Last Updated: July 8, 2014
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Novartis:
Multiple Sclerosis
MS
Fingolimod
Gilenya
ECG
Bradyarrythmia
conduction abnormalities
first dose observation

Additional relevant MeSH terms:
Multiple Sclerosis
Sclerosis
Multiple Sclerosis, Relapsing-Remitting
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Pathologic Processes
Fingolimod
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 21, 2014