A 18-month, open-label, rater-blinded, randomized, multi-center, active-controlled, parallel-group pilot study to assess efficacy and safety of fingolimod (Gilenya) in comparison to interferon beta-1b in treating the cognitive symptoms associated to relapsing-remitting multiple sclerosis and to assess possible relationship of these effects to regional brain atrophy.
- Registry ID
- EUCTR2010-023023-19
- Source registry
- EUCTR
- Status
- Completed
- Phase
- PHASE3
- Sponsor
- NOVARTIS FARMA
- Start date
- 2010-12-28
- Completion date
- 2015-09-01
- Last update
- 2026-08-16
Conditions
- relapsing-remitting multiple sclerosis
- treating of cognitive symptoms in relapsing-remitting multiple sclerosis
Summary
The primary objective 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.
Locations
View on source registry