Phase 2
Completed N=281
Efficacy and Safety of FTY720 in Patients With Relapsing Multiple Sclerosis
Source: ClinicalTrials.gov NCT00333138 ↗Enrolled (actual)
281
Serious AEs
27.1%
Results posted
Oct 2012
Primary outcomePrimary: Mean Number of Gadolinium (Gd)-Enhanced T1-weighted Lesions at Month 6 (Core) — 2.3; 1.4; 0.4 GD- enhanced T1 lesions
Summary
This study evaluated the safety, tolerability and effect on MRI lesion parameters of FTY720 in patients with relapsing multiple sclerosis.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Number of Gadolinium (Gd)-Enhanced T1-weighted Lesions at Month 6 (Core) |
2.3; 1.4; 0.4 | — |
| PRIMARY Mean Number of Gadolinium (Gd)-Enhanced T1-weighted Lesions at Month 12 |
0.4; 1.0; 0.2 | — |
| PRIMARY Mean Number of Gadolinium (Gd)-Enhanced T1-weighted Lesions at Month 60 |
0.2; 0.2; 0.1 | — |
| PRIMARY Mean Number of Gadolinium (Gd)-Enhanced T1-weighted Lesions at End of Study |
0.8; 0.4; 0.5 | — |
| SECONDARY Percentage of Participants Free of T1-weighted Lesions |
49.5; 52.2; 48.4; 47.0; 76.7; 78.2 | — |
| SECONDARY Percentage of Patients Free of Gd-enhanced T1-weighted and New T2- Weighted Lesions by Visit |
47.5; 77.0; 80.7; 57.1; 67.5; 72.9 | — |
| SECONDARY Mean Number of New T2-weighted Lesions |
1.0; 0.5; 0.1; 0.8; 1.4; 0.6 | — |
| SECONDARY Volume of T2-weighted Lesions |
9016.0; 10084.6; 8331.1; 8264.1; 10707.1; 8363.2 | — |
| SECONDARY Change From Baseline in Volume of Total T2-weighted Lesions |
146.15; -115.81; -607.97; 144.96; 1.66; -513.35 | — |
| SECONDARY Time to Event Analysis: Kaplan Meier Estimates of Percentage of Relapse-free Patients |
1.00; 1.00; 1.00; 0.69; 0.86; 0.86 | — |
| SECONDARY Mean Trough Blood Concentrations of FTY720 |
7.64; 30.5; 7.38; 28.9 | — |
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT00333138). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.