drugset / Trial / NCT01333501

Fingolimod Versus Interferon Beta 1b in Cognitive Symptoms

NCT01333501

Phase 4 Completed 151 enrolled Novartis Pharmaceuticals
RandomizedParallel-groupOpen-labelTreatment

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

Drugs

EvaluationDrugModalityDoseRoute
Subject Fingolimod Small molecule 0.5 mg Oral
Comparator Interferon beta-1b Protein / enzyme biologic 250 ug Subcutaneous

Indications