Phase 2
Completed N=143
An Extension Study of the Efficacy and Safety of Fingolimod (FTY720) in Patients With Relapsing Multiple Sclerosis
Source: ClinicalTrials.gov NCT00670449 ↗Enrolled (actual)
143
Serious AEs
13.3%
Results posted
Sep 2013
Primary outcomePrimary: Percentage of Patients Free of Gd-enhanced T1 Weighted Magnetic Resonance Imaging (MRI) Lesions — 88.6; 97.9; 58.0; 90.9 Percentage of patients
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Patients Free of Gd-enhanced T1 Weighted Magnetic Resonance Imaging (MRI) Lesions |
88.6; 97.9; 58.0; 90.9; 94.9; 92.7 | — |
| SECONDARY Percentage of Patients Free of New or Newly Enlarged T2 Weighted MRI Lesions |
69.4; 60.0; 45.1; 86.0; 91.5; 43.8 | — |
| SECONDARY Aggregate Annualized Relapse Rate (ARR) Based on Confirmed Relapses |
0.539; 0.404; 1.131; 0.227; 0.284; 0.232 | — |
| SECONDARY Percentage of Patients Relapse-free at the End of the Study |
45.2; 62.1; 48.3 | — |
| SECONDARY Percentage of Patients Free From 3-month and 6-month Confirmed Disability Progression at Their Last Expanded Disability Status Scale (EDSS) Assessment |
74.3; 82.4; 90.6; 87.1; 90.7; 92.3 | — |
| SECONDARY Change From Core Study Baseline in the Expanded Disability Status Scale (EDSS) Score |
-0.02; -0.02; -0.23; -0.12; -0.06; -0.21 | — |
Eligibility 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.
Data sourced from ClinicalTrials.gov (NCT00670449). 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.