An Extension Study of the Efficacy and Safety of Fingolimod (FTY720) i
An Extension of the 6-month, Double-blind, Randomized, Placebo-controlled, Parallel-group, Multicenter Study Comparing Efficacy and Safety of FTY720 0.5 mg and 1.25 mg Administered Orally Once Daily in Patients With Relapsing Multiple Sclerosis
What it found
Results are posted in the registry, but without a statistical test of the main measure. See the numbers below.
What was tested
Treatment tested
Results by group
Percentage of Patients Free of Gd-enhanced T1 Weighted Magnetic Resonance Imaging (MRI) Lesions
Months 6, 9, 12, 18, 24, 36, and 48
| Group | Value | Interval | Number analysed |
|---|---|---|---|
| Fingolimod 0.5 mg | 88.6 Percentage of patients | 57 | |
| Fingolimod 1.25 mg | 97.9 Percentage of patients | 54 | |
| Placebo-fingolimod | 58.0 Percentage of patients | 57 | |
| Fingolimod 0.5 mg | 90.9 Percentage of patients | 57 | |
| Fingolimod 1.25 mg | 94.9 Percentage of patients | 54 | |
| Placebo-fingolimod | 92.7 Percentage of patients | 57 | |
| Fingolimod 0.5 mg | 97.7 Percentage of patients | 57 | |
| Fingolimod 1.25 mg | 97.6 Percentage of patients | 54 | |
| Placebo-fingolimod | 88.9 Percentage of patients | 57 | |
| Fingolimod 0.5 mg | 92.9 Percentage of patients | 57 | |
| Fingolimod 1.25 mg | 92.5 Percentage of patients | 54 | |
| Placebo-fingolimod | 94.6 Percentage of patients | 57 | |
| Fingolimod 0.5 mg | 94.7 Percentage of patients | 57 | |
| Fingolimod 1.25 mg | 94.9 Percentage of patients | 54 | |
| Placebo-fingolimod | 90.9 Percentage of patients | 57 | |
| Fingolimod 0.5 mg | 92.0 Percentage of patients | 57 | |
| Fingolimod 1.25 mg | 85.7 Percentage of patients | 54 | |
| Placebo-fingolimod | 90.9 Percentage of patients | 57 | |
| Fingolimod 0.5 mg | 100.0 Percentage of patients | 57 | |
| Fingolimod 1.25 mg | 75.0 Percentage of patients | 54 | |
| Placebo-fingolimod | 100.0 Percentage of patients | 57 |
Values as posted on ClinicalTrials.gov. Outcomes measured differently across trials are not directly comparable.
Safety
| Group | Participants at risk | Serious adverse events | Deaths |
|---|---|---|---|
| Fingolimod 1.25 mg | 46 | 5 (10.9%) | |
| Fingolimod 0.5 mg | 47 | 8 (17.0%) | |
| Placebo-fingolimod 1.25 mg | 23 | 5 (21.7%) | |
| Placebo-fingolimod 0.5 mg | 27 | 1 (3.7%) |
As posted on ClinicalTrials.gov. Serious adverse events include any serious health event during the trial, whether or not the treatment caused it.
What it measured
Main measures
Percentage of Patients Free of Gd-enhanced T1 Weighted Magnetic Resonance Imaging (MRI) Lesions
Months 6, 9, 12, 18, 24, 36, and 48
MRI lesions
Other measures (5)
Percentage of Patients Free of New or Newly Enlarged T2 Weighted MRI Lesions
Months 0-3, 3-6, 6-9, 9-12, 12-18, 18-24, 24-36,36-48, and 48 to the end of the study (up to 4 years)
MRI lesionsAggregate Annualized Relapse Rate (ARR) Based on Confirmed Relapses
Months 0-6, 6-12, 12-24, 24-36, 36-48, and 48 to the end of the study (up to 4 years)
Disability progressionRelapsesBladder, bowel and sexual functionPercentage of Patients Relapse-free at the End of the Study
Baseline to the end of the study (up to 4 years)
RelapsesPercentage of Patients Free From 3-month and 6-month Confirmed Disability Progression at Their Last Expanded Disability Status Scale (EDSS) Assessment
Baseline to the end of the study (up to 4 years)
Disability progressionBladder, bowel and sexual functionChange From Core Study Baseline in the Expanded Disability Status Scale (EDSS) Score
Baseline to Months 12, 24, 36, 48, and end of study (up to 4 years)
Disability progressionBladder, bowel and sexual function
Who could take part
Relapsing MS · 18 to 60
Show the full criteria
Inclusion criteria
* Patients who completed 6 months of treatment with the study drug and the Month 6 visit in the core study NCT00537082. * Females of childbearing potential who have a negative pregnancy test in the core study NCT00537082.
Exclusion criteria
* Patients who permanently discontinued study drug treatment prior to the Month 6 visit in the core study NCT00537082. Other protocol-defined inclusion/exclusion criteria applied to the study.
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
This study was an extension study of NCT00537082. This study was designed to evaluate the efficacy and safety of long-term administration of 0.5 mg or 1.25 mg of fingolimod (FTY720) to relapsing multiple sclerosis.
Papers
Results
Long-term efficacy and safety of fingolimod in Japanese patients with relapsing multiple sclerosis: 3-year results of the phase 2 extension study.BMC Neurol · 2017
Results
Fingolimod (FTY720) therapy in Japanese patients with relapsing multiple sclerosis over 12 months: results of a phase 2 observational extension.BMC Neurol · 2014
Loading reviews and guidelines…
Linked trials
Extension of
Efficacy and Safety of FTY720 in Patients With Relapsing Multiple SclePhase 2 · Completed
Links found where a registry record names another trial's registry number.
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History
Started
Apr 2008
Main results due
Apr 2012
Finished
Apr 2012
Results posted
Sept 2013