NCT00340834

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

A 12-month Double-blind, Randomized, Multicenter, Active-controlled, Parallel-group Study Comparing the Efficacy and Safety of 0.5 mg and 1.25 mg Fingolimod (FTY720) Administered Orally Once Daily Versus Interferon ß-1a (Avonex) Administered im Once Weekly in Patients With Relapsing-remitting Multiple Sclerosis With Optional Extension Phase

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,292 (actual)
• Sponsor: Novartis · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Not accepted

Summary

This study assessed the safety, tolerability, and efficacy of 2 doses of oral fingolimod versus interferon β-1a to reduce the frequency of relapses in patients with relapsing-remitting multiple sclerosis.

Conditions

• Multiple Sclerosis

Interventions

Type	Name	Description
DRUG	Fingolimod 1.25 mg	Core: Patients self-administered fingolimod 1.25 mg capsules orally once daily. In addition, they self-administered an interferon β-1a placebo intramuscular (im) injection once weekly. Extension: Patients self-administered fingolimod 1.25 mg capsules orally once daily until switched to 0.5 mg capsules upon study protocol amendment.
DRUG	Fingolimod 0.5 mg	Core: Patients self-administered fingolimod 0.5 mg capsules orally once daily. In addition, they self-administered an interferon β-1a placebo intramuscular (im) injection once weekly. Extension: Patients self-administered fingolimod 0.5 mg capsules orally once daily.
DRUG	Interferon β-1a 30 µg	Core: Patients self-administered interferon β-1a 30 μg in an intramuscular (im) injection once weekly. In addition, they self-administered a fingolimod placebo capsule orally once daily. Extension: Patients self-administered either fingolimod 1.25 mg or 0.5 mg capsules orally once daily until switched to 0.5 mg capsules upon study protocol amendment.

Timeline

• Start date: 2006-05-01
• Primary completion: 2011-07-01
• Completion: 2011-07-01
• First posted: 2006-06-21
• Last updated: 2017-09-21
• Results posted: 2011-05-16

Locations

170 sites across 18 countries: United States, Argentina, Australia, Austria, Belgium, Brazil, Canada, Egypt, France, Germany, Greece, Hungary, Italy, Portugal, South Korea, Spain, Switzerland, United Kingdom