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.

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.