Efficacy of Fingolimod in de Novo Patients Versus Fingolimod in Patients Previously Treated With a First Line Disease Modifying Therapy

Summary

This study assessed the efficacy of fingolimod in patients with short duration relapsing-remitting multiple sclerosis who had not been previously treated with disease-modifying therapies (DMTs), versus patients with the same disease duration who had previously received first-line DMTs.

Timeline

Start

2011-12-24

Primary completion

2015-12-26

Completion

2015-12-26

Outcome

Missed primary endpoint

registry MEAN Previously Treated With First-line DMTs Participants: 0.354 (Standard Deviation 0.8547) Relapses per year NCT01498887 ↗

registry p = 0.3118; Wilcoxon (Mann-Whitney) NCT01498887 ↗

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Fingolimod	Small molecule	0.5 mg	Oral

Indications