Overview
Safety and Tolerability of Fingolimod in Patients With Relapsing-remitting Multiple Sclerosis
Status:
Completed
Completed
Trial end date:
2014-04-01
2014-04-01
Target enrollment:
0
0
Participant gender:
All
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 3Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
Novartis PharmaceuticalsTreatments:
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.