Long-term Efficacy and Safety of Fingolimod (FTY720) in Patients With Relapsing-remitting Multiple Sclerosis

Novartis

Status and phase: Completed; Phase 3

Conditions: Multiple Sclerosis

Treatments: Drug: Fingolimod 1.25 mg; Drug: Fingolimod 0.5 mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT00662649

CFTY720D2301E1

2007-004122-24 (EudraCT Number)

Details and patient eligibility

About

This extension study of was designed to evaluate the long-term safety, tolerability, and efficacy of fingolimod (FTY720) in patients with multiple sclerosis. The Extension study was an extension to the 24-month Core study (CFTY720D2301/NCT00289978).

Enrollment: 920 patients

Sex: All

Ages: 20 to 58 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients should complete the 24 month core study

Exclusion criteria

• Patients with other chronic disease of the immune system, malignancies, acute pulmonary disease, cardiac failure, etc.
• Pregnant or nursing women

Other protocol-defined inclusion/exclusion criteria may apply.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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920 participants in 5 patient groups

Fingolimod 1.25 mg

Experimental group

Description:

Patients continued the same dose to which they had been randomized in the Core study (CFTY720D2301/NCT00289978), fingolimod 1.25 mg/day, in this Extension study.

Treatment:

Drug: Fingolimod 1.25 mg

Fingolimod 0.5 mg

Experimental group

Description:

Patients continued the same dose to which they had been randomized in the Core study, fingolimod 0.5 mg/day, in this Extension study.

Treatment:

Drug: Fingolimod 0.5 mg

Placebo-fingolimod

Experimental group

Description:

Patients randomized to placebo in the Core study were re randomized to fingolimod (either 0.5 or 1.25 mg/day) in this Extension study.

Treatment:

Drug: Fingolimod 0.5 mg

Drug: Fingolimod 1.25 mg

Placebo-fingolimod 1.25 mg

Experimental group

Description:

Patients randomized to placebo in the Core study were re randomized to fingolimod 1.25 mg/day in this Extension study.

Treatment:

Drug: Fingolimod 1.25 mg

Placebo-fingolimod 0.5 mg

Experimental group

Description:

Patients randomized to placebo in the Core study were re randomized to fingolimod 0.5 mg/day in this Extension study.

Treatment:

Drug: Fingolimod 0.5 mg