CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 4,125 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/NCT01201356
NCT01201356Phase 3Completed
CompareCT.gov

A Single Arm, Open-label, Multicenter Study Evaluating the Long-term Safety and Tolerability of 0.5 mg Fingolimod (FTY720) Administered Orally Once Daily in Patients With Relapsing Forms of Multiple Sclerosis

Novartis Pharmaceuticals·interventional·Posted Sep 14, 2010·Updated Apr 21, 2021

In Brief

A Phase 3 clinical trial evaluating Fingolimod for Relapsing Forms of Multiple Sclerosis. Completed, enrolled 4,125 participants across 458 sites in 38 countries.

Detailed Summary

The purpose of this study was to collect long-term safety and tolerability, long-term efficacy, and health outcome data in all patients currently ongoing in the fingolimod multiple sclerosis clinical development program. This study combined all currently ongoing Phase II and III fingolimod extension studies as well as ongoing and newly planned studies into one single long-term extension protocol that provided patients with continuous treatment until fingolimod was registered, commercially available, and reimbursed in the respective countries.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsRelapsing Forms of Multiple Sclerosis
CountriesArgentina, Australia, Austria, Belgium, Brazil, Canada, Czechia, Denmark, Egypt, Estonia, Finland, France, Germany, Greece, Guatemala, Hungary, Ireland, Israel, Italy, Jordan, Malaysia, Netherlands, Norway, Panama, Peru, Poland, Portugal, Romania, Russia, Slovakia, South Africa, South Korea, Spain, Sweden, Switzerland, Turkey (Türkiye), United Kingdom, United States
Collaborators--

Timeline

Phase 3CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedSep 14, 2010
Enrollment StartSep 13, 2010
Primary CompletionOct 19, 2018
TodayJul 2, 2026
Enrollment to primary: 8.1 yearsPosted 15.8 years ago

Interventions

Fingolimoddrug

0.5 mg/day