Efficacy and Safety of FTY720 in Patients With Relapsing Multiple Scle
A 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
The main measure showed a statistically significant benefit.
“Higher proportions of patients were free from Gd-enhanced lesions at months 3 and 6 with fingolimod (0.5 mg: 70%, p = 0.004; 1.25 mg: 86%, p < 0.001) than with placebo (40%).”Read by software from the paper's abstract
months 3 and 6
| Group | n | Value |
|---|---|---|
| fingolimod 0.5 mg | 70% | |
| placebo | 40% |
p = 0.004 (0.5 mg vs placebo); p < 0.001 (1.25 mg vs placebo)
Total participants: 171
Read by software from the paper's abstract
What was tested
Treatment tested
Placebo
- Placebo
Results by group
Number of Patients Free of Gadolinium-enhanced T1-Weighted Magnetic Resonance Imaging (MRI) Lesions at Both Month 3 and Month 6
Month 3 and Month 6
| Group | Value | Interval | Number analysed |
|---|---|---|---|
| FTY720 1.25 mg | 43 Participants | 50 | |
| FTY720 0.5 mg | 35 Participants | 50 | |
| Placebo | 21 Participants | 52 |
FTY720 1.25 mg
FTY720 0.5 mg
Placebo
Values as posted on ClinicalTrials.gov. Outcomes measured differently across trials are not directly comparable.
Safety
| Group | Participants at risk | Serious adverse events | Deaths |
|---|---|---|---|
| FTY720 1.25mg | 54 | 11 (20.4%) | |
| FTY720 0.5mg | 57 | 5 (8.8%) | |
| Placebo | 57 | 3 (5.3%) |
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
Number of Patients Free of Gadolinium-enhanced T1-Weighted Magnetic Resonance Imaging (MRI) Lesions at Both Month 3 and Month 6
Month 3 and Month 6
RelapsesMRI lesions
Other measures (3)
Number of Patients Free of MS Relapse up to Month 6 (Confirmed Relapse Only)
up to Month 6
Disability progressionRelapsesBladder, bowel and sexual functionNumber of Patients Free of New or Newly Enlarged T2 Lesions
up to Month 3 and up to Month 6
MRI lesionsAnnualized Relapse Rate (ARR) at 6 Months
6 Months
Relapses
Who could take part
Relapsing MS · 18 to 60
Show the full criteria
Inclusion criteria
* Male and female patients aged 18-60 * Patients with a diagnosis of multiple sclerosis
Exclusion criteria
* Patients with a history or presence of chronic disease of the immune system other than MS * Patients with a history or presence of malignancy, pulmonary or heart disease, etc. * Pregnant or nursing (lactating) women Other protocol-defined inclusion/exclusion criteria may apply
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
To provide efficacy and safety data of two doses (0.5 mg and 1.25 mg) of FTY720 in Japanese patients with relapsing multiple sclerosis (MS)
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
Results
Saida T, Kikuchi S, Itoyama Y, Hao Q, Kurosawa T, Nagato K, Tang D, Zhang-Auberson L, Kira J. A randomized, controlled trial of fingolimod (FTY720) in Japanese patients with multiple sclerosis. Mult Scler. 2012 Sep;18(9):1269-77. doi: 10.1177/1352458511435984. Epub 2012 Feb 21.Higher proportions of patients were free from Gd-enhanced lesions at months 3 and 6 with fingolimod (0.5 mg: 70%, p = 0.004; 1.25 mg: 86%, p < 0.001) than with placebo (40%).
Read by software from the paper's abstract
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Linked trials
Extended by
An Extension Study of the Efficacy and Safety of Fingolimod (FTY720) iPhase 2 · Completed
Links found where a registry record names another trial's registry number.
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History
Started
Sept 2007
Main results due
Feb 2010
Results posted
Mar 2011