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

Novartis

Status and phase

Completed

Phase 3

Conditions

Multiple Sclerosis

Treatments

Drug: Fingolimod

Study type

Interventional

Funder types

Industry

Identifiers

NCT01497262

CFTY720D2325

Details and patient eligibility

About

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.

Enrollment

162 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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.