NCT00670449

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

An Extension of the 6-month, Double-blind, Randomized, Placebo-controlled, Parallel-group, Multicenter Study Comparing Efficacy and Safety of FTY720 0.5 mg and 1.25 mg Administered Orally Once Daily in Patients With Relapsing Multiple Sclerosis

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 143 (actual)
• Sponsor: Novartis · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed 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.

Conditions

• Multiple Sclerosis

Interventions

Type	Name	Description
DRUG	Fingolimod	Fingolimod was supplied in capsules.

Timeline

• Start date: 2008-04-01
• Primary completion: 2012-04-01
• Completion: 2012-04-01
• First posted: 2008-05-01
• Last updated: 2013-09-04
• Results posted: 2013-09-04

Locations

20 sites across 1 country: Japan