Phase 3
Completed N=1,272
Efficacy and Safety of Fingolimod in Patients With Relapsing-remitting Multiple Sclerosis
Source: ClinicalTrials.gov NCT00289978 ↗Enrolled (actual)
1,272
Serious AEs
11.8%
Results posted
Mar 2011
Primary outcomePrimary: Estimated Annualized Aggregate Relapse Rate (ARR) — 0.16; 0.18; 0.40 Relapses per year
Summary
This study assessed the efficacy, safety, and tolerability of 2 doses of oral fingolimod (1.25 mg/day and 0.5 mg/day) compared to placebo in patients with relapsing-remitting multiple sclerosis (RRMS)
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Estimated Annualized Aggregate Relapse Rate (ARR) |
0.16; 0.18; 0.40 | — |
| SECONDARY Percentage of Patients Free of Disability Progression at Month 24 Assessed With the Expanded Disability Status Scale (EDSS) |
83.4; 82.3; 75.9 | — |
| SECONDARY Number of New or Newly Enlarged T2 Lesions at Month 24 in Comparison With Baseline |
2.5; 2.5; 9.8 | — |
Eligibility Criteria
Inclusion Criteria
- Male and female patients between ages 18-55 with a diagnosis of multiple sclerosis
- Patients with a relapsing-remitting disease course
- Patients with EDSS score of 0-5.5
Exclusion Criteria
- Patients with other chronic disease of the immune system, malignancies, acute pulmonary disease, cardiac failure, etc.
- Pregnant or nursing women
Other protocol-defined inclusion/exclusion criteria applied to this study.
Data sourced from ClinicalTrials.gov (NCT00289978). 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.