Efficacy and Safety of FTY720 in Patients With Relapsing Multiple Sclerosis

Novartis

Status and phase: Completed; Phase 2

Conditions: Multiple Sclerosis

Treatments: Drug: FTY720; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00333138

CFTY720D2201E1 (Other Identifier)

CFTY720D2201

Details and patient eligibility

About

This study evaluated the safety, tolerability and effect on MRI lesion parameters of FTY720 in patients with relapsing multiple sclerosis.

Enrollment: 281 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Core Study

Inclusion Criteria:

• Diagnosis of relapsing multiple Sclerosis (MS)
• Patients with at least two documented relapses in the previous 2 years or one documented relapse in the last year
• Patients with an Expanded Disability Status Scale (EDSS) score of 0-6

Extension Study

• A positive Gd-enhanced MRI scan at screening (in case the first MRI scan obtained at screening was negative, a second scan could have been obtained 1 month later)
• Neurologically stable with no evidence of relapse within 30 days prior to randomization,or during the Screening and Baseline periods.
• Female patients either post-menopausal, surgically incapable of bearing children, or practicing an acceptable method of birth control. Females of childbearing potential with a negative pregnancy test at baseline prior to entry into the treatment period.

Exclusion Criteria:

Core Study

• Patients with other chronic disease of the immune system, malignancies, pulmonary or heart disease, etc
• Pregnant or nursing women

Extension Study

• Patients who had permanently discontinued study drug prior to the Month 6 visit of the core study
• Patients with diabetes mellitus (to reduce the risk of ME), and therefore ongoing patients with diabetes mellitus or who developed diabetes mellitus were discontinued from the study)

Other protocol-defined inclusion/exclusion criteria may apply

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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281 participants in 3 patient groups, including a placebo group

Fingolimod (FTY720) 1.25 mg/day

Experimental group

Description:

Core study: patients received fingolimod 1.25 mg, once daily for 6 months. Extension: In dose -blind period and open label, fingolimod 1.25 mg once daily for 9-18 months (6 months to 24 months). Later, all patients converted to fingolimod 0.5 mg, once daily for rest of the study participation.

Treatment:

Drug: FTY720

Placebo/Fingolimod (FTY720)

Placebo Comparator group

Description:

Core study: patients received placebo, once daily for 6 months. Extension: In dose-blind period patients were re-randomized into either fingolimod 1.25 mg or 5.0 mg once per day for 6-15 months. In open-label period patients received fingolimod 1.25 mg once per day for 15 to 24 months. Later, all patients converted to fingolimod 0.5 mg, once daily for rest of the study participation.

Treatment:

Drug: Placebo

Fingolimod (FTY720) 5.0 mg/day

Experimental group

Description:

Core study: patients received fingolimod 5.0 mg, once daily for 6 months. Extension: In dose-blind period fingolimod 5.0 mg once daily for 6-15 months. For open-label phase 15 to 24 months 1.25mg once daily. Later, all patients converted to fingolimod 0.5 mg, once daily for rest of the study participation.

Treatment:

Drug: FTY720