NCT00289978

Efficacy and Safety of Fingolimod in Patients With Relapsing-remitting Multiple Sclerosis

A 24-month, Double-blind, Randomized, Multicenter, Placebo-controlled, Parallel-group Study Comparing the Efficacy and Safety of Fingolimod 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: 1,272 (actual)
• Sponsor: Novartis · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Not accepted

Summary

This study assessed the efficacy, safety, and tolerability of 2 doses of oral fingolimod (1.25 mg/day and 0.5 mg/day) compared to placebo in patients with relapsing-remitting multiple sclerosis (RRMS)

Conditions

• Relapsing-remitting Multiple Sclerosis

Interventions

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

Timeline

• Start date: 2006-01-01
• Primary completion: 2009-07-01
• Completion: 2009-07-01
• First posted: 2006-02-10
• Last updated: 2012-04-11
• Results posted: 2011-03-16

Locations

115 sites across 19 countries: Australia, Belgium, Canada, Czechia, Finland, France, Germany, Greece, Israel, Lithuania, Netherlands, Poland, Russia, Slovakia, South Africa, Sweden, Switzerland, Turkey (Türkiye), United Kingdom