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

NCT01941004 Phase 3 WITHDRAWN

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

Details

Lead sponsor	Novartis Pharmaceuticals
Phase	Phase 3
Status	WITHDRAWN
Start date	2014-06
Completion	2017-05

Conditions

• Multiple Sclerosis (Relapsing Remitting)

Interventions

• fingolimod
• Placebo (6mos) + open label fingolimod (6 mos)

Primary outcomes

• number of new/newly enlarged T2 MRI lesions over 6 months — 6 months
  Cumulative number of new/newly enlarged T2 lesions over 6 months