Efficacy and Safety of FTY720 in Patients With Relapsing Multiple Sclerosis: fingolimod in relapsing MS, phase 2

Double-blind, Randomized, Placebo-controlled, Parallel-group, Multicenter Study Evaluating the Safety, Tolerability and Effect on MRI Lesion Parameters of FTY720 vs Placebo in Patients With Relapsing Multiple Sclerosis Including 18 Month Extension Phase

CompletedPhase 2Relapsing MSNCT00333138

What it found

Met its main goal

The main measure showed a statistically significant benefit.

“The median total number of gadolinium-enhanced lesions on MRI was lower with 1.25 mg of fingolimod (1 lesion, P<0.001) and 5.0 mg of fingolimod (3 lesions, P=0.006) than with placebo (5 lesions).”

Read by software from the paper's abstract

total number of gadolinium-enhanced lesions recorded on T(1)-weighted MRI at monthly intervals for 6 months · 6 months

Group	n	Value
Placebo		median 5 lesions

p = <0.001 (1.25 mg vs placebo); P=0.006 (5.0 mg vs placebo)

Total participants: 281

Read by software from the paper's abstract

What was tested

Treatment tested

Fingolimod

Placebo

Placebo

Results by group

Mean Number of Gadolinium (Gd)-Enhanced T1-weighted Lesions at Month 6 (Core)

Month 6 (Core)

Group	Value	Interval	Number analysed
Placebo	2.3 GD- enhanced T1 lesions	4.23 (Standard Deviation)	83
Fingolimod (FTY720) 1.25 mg/Day	1.4 GD- enhanced T1 lesions	5.69 (Standard Deviation)	90
Fingolimod (FTY720) 5.0 mg/Day	0.4 GD- enhanced T1 lesions	0.82 (Standard Deviation)	87

Placebo

Fingolimod (FTY720) 1.25 mg/Day

Fingolimod (FTY720) 5.0 mg/Day

Mean Number of Gadolinium (Gd)-Enhanced T1-weighted Lesions at Month 12

Month 12 (extension)

Group	Value	Interval	Number analysed
Placebo	0.4 GD- enhanced T1 lesions	0.95 (Standard Deviation)	72
Fingolimod (FTY720) 1.25 mg/Day	1.0 GD- enhanced T1 lesions	5.81 (Standard Deviation)	77
Fingolimod (FTY720) 5.0 mg/Day	0.2 GD- enhanced T1 lesions	0.47 (Standard Deviation)	71

Placebo

Fingolimod (FTY720) 1.25 mg/Day

Fingolimod (FTY720) 5.0 mg/Day

Mean Number of Gadolinium (Gd)-Enhanced T1-weighted Lesions at Month 60

Month 60 (extension)

Group	Value	Interval	Number analysed
Placebo	0.2 GD- enhanced T1 lesions	0.7 (Standard Deviation)	45
Fingolimod (FTY720) 1.25 mg/Day	0.2 GD- enhanced T1 lesions	0.92 (Standard Deviation)	49
Fingolimod (FTY720) 5.0 mg/Day	0.1 GD- enhanced T1 lesions	0.55 (Standard Deviation)	44

Placebo

Fingolimod (FTY720) 1.25 mg/Day

Fingolimod (FTY720) 5.0 mg/Day

Mean Number of Gadolinium (Gd)-Enhanced T1-weighted Lesions at End of Study

Last observation (Up to 80 months in average)

Group	Value	Interval	Number analysed
Placebo	0.8 GD- enhanced T1 lesions	2.87 (Standard Deviation)	92
Fingolimod (FTY720) 1.25 mg/Day	0.4 GD- enhanced T1 lesions	1.39 (Standard Deviation)	93
Fingolimod (FTY720) 5.0 mg/Day	0.5 GD- enhanced T1 lesions	1.65 (Standard Deviation)	92

Placebo

Fingolimod (FTY720) 1.25 mg/Day

Fingolimod (FTY720) 5.0 mg/Day

Values as posted on ClinicalTrials.gov. Outcomes measured differently across trials are not directly comparable.

Safety

Group	Participants at risk	Serious adverse events
Placebo	93	25 (26.9%)
Fingolimod (FTY720) 1.25 mg	94	19 (20.2%)
Fingolimod (FTY720) 5.0 mg	94	32 (34.0%)

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

Mean Number of Gadolinium (Gd)-Enhanced T1-weighted Lesions at Month 6 (Core)
Month 6 (Core)
MRI lesions
Mean Number of Gadolinium (Gd)-Enhanced T1-weighted Lesions at Month 12
Month 12 (extension)
MRI lesions
Mean Number of Gadolinium (Gd)-Enhanced T1-weighted Lesions at Month 60
Month 60 (extension)
MRI lesions
Mean Number of Gadolinium (Gd)-Enhanced T1-weighted Lesions at End of Study
Last observation (Up to 80 months in average)
MRI lesions

Other measures (7)

Percentage of Participants Free of T1-weighted Lesions
Baseline, Months 6 (core), 12, 60 and Last Observation (up to 80 months in average)
MRI lesions
Percentage of Patients Free of Gd-enhanced T1-weighted and New T2- Weighted Lesions by Visit
Month 6 and 12, 60, last observation (up to 80 months in average)
MRI lesions
Mean Number of New T2-weighted Lesions
(Core) Month 6 and (Extension) 12, 60, last observation (up to 80 months in average)
MRI lesions
Volume of T2-weighted Lesions
(Core) Month 6 and (Extension) 12, 60, last observation (up to 80 months in average)
MRI lesions
Change From Baseline in Volume of Total T2-weighted Lesions
Baseline to month 6, 12, 60 and Last observation (up to 80 months in average)
MRI lesions
Time to Event Analysis: Kaplan Meier Estimates of Percentage of Relapse-free Patients
Month 6,12,60 and Last observation (up to 80 months in average)
Disability progressionRelapsesBladder, bowel and sexual function
Mean Trough Blood Concentrations of FTY720
Month 3 and 6
How the body handles the medicine

Who could take part

Relapsing MS · 18 to 60 · EDSS 0 to 6

Show the full criteria

Inclusion criteria

Core Study Inclusion Criteria: * Diagnosis of relapsing multiple Sclerosis (MS) * Patients with at least two documented relapses in the previous 2 years or one documented relapse in the last year * Patients with an Expanded Disability Status Scale (EDSS) score of 0-6 Extension Study * A positive Gd-enhanced MRI scan at screening (in case the first MRI scan obtained at screening was negative, a second scan could have been obtained 1 month later) * Neurologically stable with no evidence of relapse within 30 days prior to randomization,or during the Screening and Baseline periods. * Female patients either post-menopausal, surgically incapable of bearing children, or practicing an acceptable method of birth control. Females of childbearing potential with a negative pregnancy test at baseline prior to entry into the treatment period.

Exclusion criteria

Core Study * Patients with other chronic disease of the immune system, malignancies, pulmonary or heart disease, etc * Pregnant or nursing women Extension Study * Patients who had permanently discontinued study drug prior to the Month 6 visit of the core study * Patients with diabetes mellitus (to reduce the risk of ME), and therefore ongoing patients with diabetes mellitus or who developed diabetes mellitus were discontinued from the study) 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

This study evaluated the safety, tolerability and effect on MRI lesion parameters of FTY720 in patients with relapsing multiple sclerosis.

Papers

Results
Oral fingolimod (FTY720) for relapsing multiple sclerosis.
N Engl J Med · 2006
The median total number of gadolinium-enhanced lesions on MRI was lower with 1.25 mg of fingolimod (1 lesion, P<0.001) and 5.0 mg of fingolimod (3 lesions, P=0.006) than with placebo (5 lesions).
Read by software from the paper's abstract
Results
Zarbin MA, Jampol LM, Jager RD, Reder AT, Francis G, Collins W, Tang D, Zhang X. Ophthalmic evaluations in clinical studies of fingolimod (FTY720) in multiple sclerosis. Ophthalmology. 2013 Jul;120(7):1432-9. doi: 10.1016/j.ophtha.2012.12.040. Epub 2013 Mar 24.

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History

Started
May 2003
Main results due
Apr 2011
Finished
Apr 2011
Results posted
Oct 2012

Assembled by software from public sources.