Safety and Tolerability of Fingolimod in Patients With Relapsing-remitting Multiple Sclerosis

March 17, 2015 updated by: Novartis Pharmaceuticals

A 4-month, Open-label, Multi-center Study to Explore the Safety and Tolerability of Fingolimod 0.5 mg in Patients With Relapsing-remitting Multiple Sclerosis

This 4 month, open-label study will evaluate the safety and tolerability of fingolimod 0.5 mg in patients with relapsing-remitting multiple sclerosis (RRMS) and generate additional data in Multiple Sclerosis (MS) patient population that closely resembles the clinical population seen in routine medical care.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

162

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • Cordoba, Argentina, X5004CDT
        • Novartis Investigative Site
      • Salta, Argentina, A4400BKZ
        • Novartis Investigative Site
      • Salta, Argentina, A4400ANG
        • Novartis Investigative Site
    • Buenos Aires
      • Caba, Buenos Aires, Argentina, 1425
        • Novartis Investigative Site
    • Mendoza
      • Guaymallen, Mendoza, Argentina, M5507XAD
        • Novartis Investigative Site
    • Tucumán
      • San Miguel de Tucuman, Tucumán, Argentina, T4000DPB
        • Novartis Investigative Site
      • San Miguel de Tucumán, Tucumán, Argentina, 4000
        • Novartis Investigative Site
  • Brazil
    • RJ
      • Rio de Janeiro, RJ, Brazil, 21941-590
        • Novartis Investigative Site
      • Rio de Janeiro, RJ, Brazil, 20270-004
        • Novartis Investigative Site
    • RS
      • Porto Alegre, RS, Brazil, 90610-000
        • Novartis Investigative Site
  • Colombia
      • Bogotá, Colombia
        • Novartis Investigative Site
      • Bogotá, Colombia, 00000
        • Novartis Investigative Site
      • Cali, Colombia
        • Novartis Investigative Site
    • Atlantico
      • Barranquilla, Atlantico, Colombia
        • Novartis Investigative Site
    • Cundinamarca
      • Bogotá, Cundinamarca, Colombia, 110111
        • Novartis Investigative Site
  • Jordan
      • Amman, Jordan, 11942
        • Novartis Investigative Site
      • Irbid, Jordan, 22110
        • Novartis Investigative Site
  • Malaysia
      • Kuala Lumpur, Malaysia, 59100
        • Novartis Investigative Site
      • Kuala Lumpur, Malaysia, 50586
        • Novartis Investigative Site
      • Penang, Malaysia, 10990
        • Novartis Investigative Site
  • Mexico
      • San Luis Potosí, Mexico, 78240
        • Novartis Investigative Site
    • Distrito Federal
      • Mexico, Distrito Federal, Mexico, 06700
        • Novartis Investigative Site
      • México, Distrito Federal, Mexico, 10700
        • Novartis Investigative Site
    • Nuevo León
      • Monterrey, Nuevo León, Mexico, 64060
        • Novartis Investigative Site
      • San Nicolas De Los Garza, Nuevo León, Mexico, 66480
        • Novartis Investigative Site
  • Panama
    • Panamá
      • Panama City, Panamá, Panama
        • Novartis Investigative Site
  • Peru
    • Callao
      • La Perla, Callao, Peru, 04
        • Novartis Investigative Site
    • Lima
      • Jesus Maria, Lima, Peru, 11
        • Novartis Investigative Site
      • San Isidro, Lima, Peru, 27
        • Novartis Investigative Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients with relapsing remitting Multiple Sclerosis
  • Patients with Expanded Disability Status Scale (EDSS) score of 0-6.5.

Exclusion Criteria:

  • Patients with MS other than relapsing remitting MS
  • Patients with a history of chronic disease of the immune system other than MS, which requires systemic immunosuppressive treatment, or a known immunodeficiency syndrome.

  • Patients who have been treated with:

    • systemic corticosteroids or immunoglobulins within 1 month prior to baseline;
    • immunosuppressive medications within 3 months prior to baseline;
    • monoclonal antibodies within 3 months prior to baseline;
    • cladribine, mitoxantrone or alemtuzumab at any time.
  • Uncontrolled diabetes mellitus at screening
  • Diagnosis of macular edema during Screening Phase
  • Patients with active systemic bacterial, viral or fungal infections, or known to have AIDS, Hepatitis B, Hepatitis C infection or to have positive HIV antibody, Hepatitis B surface antigen or Hepatitis C antibody tests.
  • Patients who have received total lymphoid irradiation or bone marrow transplantation.
  • Patients with certain cardiovascular conditions and/or findings in the screening ECG
  • Patients with certain liver conditions
  • Pregnant confirmed by a positive pregnancy test t or nursing (lactating) women
  • Other protocol-defined inclusion/exclusion criteria may apply.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NON_RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Fingolimod
Open-label fingolimod 0.5 mg, taken orally once daily for 4 months
Drug: Fingolimod
Fingolimod will be supplied as 0.5mg capsules in bottles of 35.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants With Adverse Events as a Measure of Safety and Tolerability
Time Frame: 28 weeks
Any Adverse Event was defined as occurrence of any symptom regardless of intensity grade, Serious Adverse Event (SAEs) assessed as medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in persistent or significant disability/incapacity
28 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number (%) of Patients With AE of Special Interest Including Bradyarrhythmia, BP Increase, Liver Transaminase Elevations, Infections , Macula Oedema.
Time Frame: 4 months
The incidence of events in special areas of safety interest (including bradyarrhythmias, BP increase, liver function, infections and macular oedema) were assessed by the nature and frequency of AE reporting. These areas of special interest have been identified and potential risks of fingolimod based on knowledge from clinical trials and post-marketing reporting.
4 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novartis Pharmaceuticals

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2012

Primary Completion (ACTUAL)

April 1, 2014

Study Completion (ACTUAL)

April 1, 2014

Study Registration Dates

First Submitted

December 5, 2011

First Submitted That Met QC Criteria

December 19, 2011

First Posted (ESTIMATE)

December 22, 2011

Study Record Updates

Last Update Posted (ESTIMATE)

March 19, 2015

Last Update Submitted That Met QC Criteria

March 17, 2015

Last Verified

March 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CFTY720D2325

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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