NCT00662649

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

An Extension of the 24-month, Double-blind, Randomized, Multicenter, Placebo-controlled, Parallel-group Study Comparing Efficacy and Safety of Fingolimod (FTY720) 1.25 mg and 0.5 mg Administered Orally Once Daily Versus Placebo in Patients With Relapsing-remitting Multiple Sclerosis

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 920 (actual)
• Sponsor: Novartis · Industry
• Sex: All
• Age: 20 Years – 58 Years
• Healthy volunteers: Not accepted

Summary

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).

Conditions

• Multiple Sclerosis

Interventions

Type	Name	Description
DRUG	Fingolimod 0.5 mg	Patients self-administered fingolimod 0.5 mg capsules orally once daily.
DRUG	Fingolimod 1.25 mg	Patients self-administered fingolimod 1.25 mg capsules orally once daily.

Timeline

• Start date: 2008-02-01
• Primary completion: 2011-06-01
• Completion: 2011-06-01
• First posted: 2008-04-21
• Last updated: 2012-07-12
• Results posted: 2012-07-12

Locations

103 sites across 22 countries: Australia, Belgium, Canada, Czechia, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Israel, Netherlands, Poland, Romania, Russia, Slovakia, South Africa, Sweden, Switzerland, Turkey (Türkiye), United Kingdom