Overview

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

Status:
Completed
Trial end date:
2014-04-01
Target enrollment:
0
Participant gender:
All
Summary
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.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Novartis Pharmaceuticals
Treatments:
Fingolimod Hydrochloride
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.