An Extension Study of the Efficacy and Safety of Fingolimod (FTY720) in Patients With Relapsing Multiple Sclerosis

Novartis

Status and phase: Completed; Phase 2

Conditions: Multiple Sclerosis

Treatments: Drug: Fingolimod

Study type: Interventional

Funder types: Industry

Identifiers

NCT00670449

CFTY720D1201E1

Details and patient eligibility

About

This study was an extension study of NCT00537082. This study was designed to evaluate the efficacy and safety of long-term administration of 0.5 mg or 1.25 mg of fingolimod (FTY720) to relapsing multiple sclerosis.

Full description

A decision was made to switch all patients on fingolimod 1.25 mg/day to fingolimod 0.5 mg/day in an amendment to the study protocol. The study became open-label with all patients receiving fingolimod 0.5 mg/day on 22 Feb 2010.

The efficacy data for Months 0-6 in this study report is from the core study NCT00537082.

Enrollment: 143 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients who completed 6 months of treatment with the study drug and the Month 6 visit in the core study NCT00537082.
• Females of childbearing potential who have a negative pregnancy test in the core study NCT00537082.

Exclusion criteria

• Patients who permanently discontinued study drug treatment prior to the Month 6 visit in the core study NCT00537082.

Other protocol-defined inclusion/exclusion criteria applied to the study.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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143 participants in 3 patient groups

Fingolimod 0.5 mg

Experimental group

Description:

Patients who received fingolimod 0.5 orally once daily in the core study continued on the same dose in this extension study.

Treatment:

Drug: Fingolimod

Fingolimod 1.25 mg

Experimental group

Description:

Patients who received fingolimod 1.25 mg orally once daily in the core study continued on the same dose in this extension study.

Treatment:

Drug: Fingolimod

Placebo-fingolimod

Experimental group

Description:

Patients who were randomized to placebo in the core study were re-randomized to either fingolimod 0.5 or 1.25 mg (1:1) orally once daily in this extension study.

Treatment:

Drug: Fingolimod