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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01497262
First received: December 5, 2011
Last updated: June 4, 2014
Last verified: June 2014

December 5, 2011
June 4, 2014
February 2012
April 2014   (final data collection date for primary outcome measure)
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.

Same as current
Complete list of historical versions of study NCT01497262 on ClinicalTrials.gov Archive Site
  • 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.
Same as current
Not Provided
Not Provided
 
Safety and Tolerability of Fingolimod in Patients With Relapsing-remitting Multiple Sclerosis
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.

Not Provided
Interventional
Phase 3
Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Multiple Sclerosis
Drug: Fingolimod
Fingolimod will be supplied as 0.5mg capsules in bottles of 35.
Experimental: Fingolimod
Open-label fingolimod 0.5 mg, taken orally once daily for 4 months
Intervention: Drug: Fingolimod
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
162
April 2014
April 2014   (final data collection date for primary outcome measure)

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.
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
Argentina,   Brazil,   Colombia,   Jordan,   Malaysia,   Mexico,   Panama,   Peru
 
NCT01497262
CFTY720D2325
Not Provided
Novartis ( Novartis Pharmaceuticals )
Novartis Pharmaceuticals
Not Provided
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
Novartis
June 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP