Conditions: Multiple Sclerosis
Keywords: Multiple sclerosis cognitive symptoms relapsing-remitting multiple sclerosis (RRMS) fingolimod Magnetic resonance imaging (MRI)
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 151
Healthy volunteers: no

Brief 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.

Detailed description:

Arms:
arm 1: 0.5 mg in capsules for oral administration once daily arm 2: 250 μg injected s.c. every other day

Interventions: intervention 1: Fingolimod intervention 2: Interferon beta 1b
Intervention descriptions: intervention 1: 0.5 mg in capsules for oral administration once daily intervention 2: 250 μg injected s.c. every other day

Protocol document: