CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 87 enrolled
Drug / intervention
Fingolimoddrug
Likely dose
Fingolimod 0.5 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01705236
NCT01705236Phase 4Completed
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A 3-year Multi-center Study to Describe the Long Term Changes of Optical Coherence Tomography (OCT) Parameters in Patients Under Treatment With Gilenya®

Novartis Pharmaceuticals·interventional·Posted Oct 12, 2012·Updated Mar 2, 2020

In Brief

A Phase 4 clinical trial evaluating Fingolimod for Relapsing Remitting Multiple Sclerosis RRMS. Completed, enrolled 87 participants across 10 sites in 2 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsRelapsing Remitting Multiple Sclerosis RRMS
CountriesGermany, Switzerland
Collaborators--

Timeline

Phase 4CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedOct 12, 2012
Enrollment StartAug 20, 2012
Primary CompletionFeb 18, 2019
TodayJul 2, 2026
Enrollment to primary: 6.5 yearsPosted 13.7 years ago

Interventions

Fingolimoddrug

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.