Fingolimod Versus Interferon Beta 1b in Cognitive Symptoms

Summary

The purpose of this pilot study is to evaluate, by means of a specific cognitive test battery (Brief Repeatable Battery and Delis-Kaplan Executive Function System scale), the slowing/reduction of cognitive dysfunction progression in RRMS patients after 18 months of treatment with fingolimod in comparison with interferon beta 1b treatment, and to evaluate which test of the battery is the most sensitive in detecting differences between treatment groups.

Timeline

Start

2011-05

Primary completion

2015-09

Completion

2015-09

Outcome

Missed primary endpoint

registry analysis (superiority or other test); Fingolimod vs Interferon Beta 1b; p = 0.4940; Mean Difference (Net) 1.86 (95% CI -3.51 to 7.23); ANCOVA NCT01333501 ↗

Drugs

Indications