NCT01705236

A 3-year Multi-center Study to Describe Changes of OCT Parameters Under Treatment With Gilenya®

A 3-year Multi-center Study to Describe the Long Term Changes of Optical Coherence Tomography (OCT) Parameters in Patients Under Treatment With Gilenya®

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 87 (actual)
• Sponsor: Novartis Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

This was a 3-year, prospective, multi-center, open-label study to describe the long term changes of optical coherence tomography (OCT) parameters in RRMS patients under treatment with Fingolimod. It was designed to longitudinally study the degeneration of retinal axons by measuring change in RNFL thickness by latest OCT-technology.

Conditions

• Relapsing Remitting Multiple Sclerosis RRMS

Interventions

Type	Name	Description
DRUG	Fingolimod	All subjects received an oral dose of 0.5 mg fingolimod (FTY720) per capsule (hard gelatin capsules) once daily according to local label for the treatment of their MS.

Timeline

• Start date: 2012-08-20
• Primary completion: 2019-02-18
• Completion: 2019-02-18
• First posted: 2012-10-12
• Last updated: 2020-03-02
• Results posted: 2020-03-02

Locations

10 sites across 2 countries: Germany, Switzerland