At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 138 enrolled
Drug / intervention
Fingolimod +3 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.
A 3-month Blinded, Randomized, Multicenter, Placebo-controlled Study to Evaluate the Effect of Treatment With Fingolimod on the Immune Response Following Seasonal Influenza Vaccination and Tetanus Toxoid Booster Injection in Patients With Relapsing Forms of Multiple Sclerosis (MS)
In Brief
A Phase 3 clinical trial evaluating Fingolimod, Placebo, and 2 other interventions for Relapsing Multiple Sclerosis. Completed, enrolled 138 participants across 25 sites in 9 countries.
Detailed Summary
This study will evaluate the effect of treatment with fingolimod on the immune response following seasonal influenza vaccination and tetanus booster injection in patients with relapsing MS.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsRelapsing Multiple Sclerosis
CountriesBelgium, Canada, Finland, France, Guatemala, Poland, Spain, Switzerland, United Kingdom
Collaborators--
Timeline
Phase 3CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
Enrollment StartAug 2010
First PostedSep 2010
Primary CompletionMay 2011
TodayJul 2026
First PostedSep 13, 2010
Enrollment StartAug 1, 2010
Primary CompletionMay 1, 2011
TodayJul 2, 2026
Enrollment to primary: 9 monthsPosted 15.8 years ago
Interventions
Fingolimoddrug
Fingolimod 0.5 mg capsules for oral administration.
Placebodrug
Matching placebo capsules for oral administration.
Seasonal influenza vaccinebiological
Commercially available injectable influenza vaccine for the 2010/11 influenza season.
Tetanus toxoid vaccinebiological
Commercially available tetanus toxoid vaccine booster injection.