NCT01941004

Safety and Efficacy of Fingolimod in MS Patients in China

A 12 Month Study, With a 6-month, Double-blind, Randomized, Placebo-controlled, Multi-center Parallel- Groups, Treatment Phase Evaluating Efficacy and Safety of Fingolimod 0.5 mg and a 6-month, Open-label, Treatment Phase, in Chinese Patients With Relapsing-remitting Multiple Sclerosis

• Status: Withdrawn
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Novartis Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Not accepted

Summary

To evaluate the safety and efficacy of fingolimod 0.5mg vs. placebo in MS patients in China

Conditions

• Multiple Sclerosis (Relapsing Remitting)

Interventions

Type	Name	Description
DRUG	fingolimod	Randomized to 6 month (180 days) 0.5 mg fingolimod + 6 month (180 day) open label 0.5mg fingolimod capsules for oral administration once daily
DRUG	Placebo (6mos) + open label fingolimod (6 mos)	Randomized to 6 month (180 days) matching placebo + 6 month (180 day) open label 0.5mg fingolimod capsules for oral administration once daily

Timeline

• Start date: 2014-06-01
• Primary completion: 2017-05-01
• Completion: 2017-05-01
• First posted: 2013-09-12
• Last updated: 2017-04-21