CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 61 enrolled
Drug / intervention
Fingolimod +1 moredrug
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/NCT01317004
NCT01317004Phase 4Completed

A 6-month, Randomized, Active Comparator, Open-label, Multi-Center Study to Evaluate Patient Outcomes, Safety and Tolerability of Fingolimod (FTY720) 0.5 mg/Day in Patients With Relapsing Remitting Multiple Sclerosis Who Are Candidates for MS Therapy Change From Previous Disease Modifying Therapy (EPOC)

Novartis Pharmaceuticals·interventional·Posted Mar 16, 2011·Updated Jun 22, 2015

In Brief

A Phase 4 clinical trial evaluating Fingolimod and Standard MS DMT for Relapsing Remitting Multiple Sclerosis. Completed, enrolled 61 participants across 17 sites.

Detailed Summary

The purpose of this study is to evaluate the change in patient-reported treatment satisfaction after 6 months of treatment with fingolimod 0.5mg/day vs. DMT standard of care, using the global satisfaction subscale of the Treatment Satisfaction Questionnaire for Medication (TSQM-9).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesItaly
Collaborators--

Timeline

Phase 4CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedMar 16, 2011
Enrollment StartMay 1, 2011
Primary CompletionJun 1, 2014
TodayJul 2, 2026
Enrollment to primary: 3.1 yearsPosted 15.3 years ago

Interventions

Fingolimoddrug

0.5 mg/day oral capsule

Standard MS DMTdrug

Interferon beta 1a or interferon beta 1b or Glatiramer Acetate