NCT01499667

Disease Control and Safety in Patients With Relapsing Remitting Multiple Sclerosis (RRMS) Switching From Natalizumab to Fingolimod

A 32-week, Patient- and Rater-blinded, Randomized, Multi-center, Parallel-group Study to Evaluate Disease Control and Safety in Patients With Relapsing Remitting Multiple Sclerosis Transferred From Previous Treatment With Natalizumab to Fingolimod (FTY720)

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 142 (actual)
• Sponsor: Novartis Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

This study evaluated disease control during different lengths of treatment transition from natalizumab to fingolimod.

Detailed description

Patient were screened, signed an informed consent at visit 1, at the 2nd visit, all patient received a baseline infusion of Natalizumub and subsequently randomized to one of 3 treatment arms. At the randomization visit, the Washout Phase started, and eligible patients were randomized 1:1:1 to one of three treatment groups: * 8-week washout (8 weeks no treatment) followed by 24 weeks of treatment with fingolimod, * 12-week washout (8 weeks no treatment and 4 weeks placebo) followed by 20 weeks of treatment with fingolimod, or * 16-week washout (8 weeks no treatment and 8 weeks placebo) followed by 16 weeks of treatment with fingolimod.

Conditions

• Relapsing Remitting Multiple Sclerosis (RRMS)

Interventions

Type	Name	Description
DRUG	Fingolimod	Fingolimod 0.5 mg capsules for oral administration once daily
DRUG	Placebo	Matching placebo in capsules for oral administration once daily.

Timeline

• Start date: 2011-09-01
• Primary completion: 2012-11-01
• Completion: 2012-11-01
• First posted: 2011-12-26
• Last updated: 2014-08-08
• Results posted: 2014-04-04

Locations

44 sites across 11 countries: Australia, Austria, Czechia, Finland, Germany, Greece, Hungary, Israel, Italy, Spain, Switzerland