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

This study is currently recruiting participants.
Verified February 2013 by Novartis
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01497262
First received: December 5, 2011
Last updated: February 7, 2013
Last verified: February 2013
History of Changes
  Purpose

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.


Condition Intervention Phase
Multiple Sclerosis
 Drug: Fingolimod
 Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Novartis:

Primary Outcome Measures:
  • The incidence rate of adverse events (AEs and SAEs) [ Time Frame: 28 weeks ] [ Designated as safety issue: Yes ]

    The incidence of AEs (new or worsened from baseline) and suspected study drug related AEs or developed into an SAE after the start of the treatment will be summarized as the frequency count as well as the percentage of patients with AEs by primary system organ class (SOC), preferred term, severity and relationship to study drug.

    In addition, the incidence of death, SAEs (including infections), AEs (including infections) leading to premature discontinuation of study drug, and other significant AEs will be summarized separately by primary system organ class and preferred term.



Secondary Outcome Measures:
  • Incidence of cardiovascular (bradyarrhythmias and blood pressure increase) events during the first dose administration [ Time Frame: 1,2,3,4,5 and 6 hours ] [ Designated as safety issue: Yes ]

    Incidence of bradyarrhythmias will be assessed based on the AEs. Summary statistics for the incidence of bradyarrhythmias will be reported with the primary analyses.

    Incidence of bradyarrhythmias will be assessed up to 6 hours post initial dose. Incidence of blood pressure increase will be assessed using data from the vital signs. The frequencies and percentages of patients with blood pressure increase will be summarized.


  • Incidence of liver transaminase elevations [ Time Frame: 28 weeks ] [ Designated as safety issue: Yes ]
    Incidence of liver transaminase elevations will be assessed using data from liver function tests. The frequencies and percentages of patients with elevations of 1, 2, 3, 5, and 10 times of the upper limit of normal will be summarized.

  • Incidence of infections [ Time Frame: 28 weeks ] [ Designated as safety issue: Yes ]
    Incidence of all infections will be assessed based on the AEs. Summary statistics for the incidence of infections will be reported within the primary analyses. Infections will be summarized separately by preferred term.

  • Percentage of patient developing macular edema during the study [ Time Frame: Baseline, 16 weeks ] [ Designated as safety issue: Yes ]
    The incidence of macular edema will be assessed using data from the ophthalmic assessments (including, but not limited to, best-corrected visual acuity, dilated ophthalmoscopy, fundus examination, FA and OCT), and will be summarized as frequency distributions.


Estimated Enrollment: 300
Study Start Date: February 2012
Estimated Study Completion Date: March 2014
Estimated Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01497262

Contacts
Contact: Novartis Pharmaceuticals +41613241111
Contact: Novartis Pharmaceuticals

  Show 43 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: NCT01497262     History of Changes
Other Study ID Numbers: CFTY720D2325
Study First Received: December 5, 2011
Last Updated: February 7, 2013
Health Authority: United States: Food and Drug Administration
Brazil: Ministry of Health
Argentina: Ministry of Health
Colombia: Institutional Review Board
Jordan: Ethical Committee
Malaysia: Ministry of Health
Mexico: Ministry of Health
Panama: Ministry of Health
Peru: Ministry of Health

Keywords provided by Novartis:
Multiple Sclerosis
Relapsing-Remitting

Additional relevant MeSH terms:
Multiple Sclerosis
Multiple Sclerosis, Relapsing-Remitting
Sclerosis
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 May 16, 2013