Phase 2
Completed N=171
Efficacy and Safety of FTY720 in Patients With Relapsing Multiple Sclerosis (MS)
Source: ClinicalTrials.gov NCT00537082 ↗Enrolled (actual)
171
Serious AEs
11.3%
Results posted
Mar 2011
Primary outcomePrimary: Number of Patients Free of Gadolinium-enhanced T1-Weighted Magnetic Resonance Imaging (MRI) Lesions at Both Month 3 and Month 6 — 43; 35; 21 Participants
Summary
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)
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Patients Free of Gadolinium-enhanced T1-Weighted Magnetic Resonance Imaging (MRI) Lesions at Both Month 3 and Month 6 |
43; 35; 21 | — |
| SECONDARY Number of Patients Free of MS Relapse up to Month 6 (Confirmed Relapse Only) |
45; 45; 37 | — |
| SECONDARY Number of Patients Free of New or Newly Enlarged T2 Lesions |
30; 34; 23; 28; 31; 18 | — |
| SECONDARY Annualized Relapse Rate (ARR) at 6 Months |
0.407; 0.512; 1.131 | — |
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT00537082). 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.