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