Efficacy and Safety of Fingolimod in Patients With Relapsing-remitting Multiple Sclerosis

• Status: Completed
• Trial end date: 2009-07-01
• Target enrollment: 0
• Participant gender: All

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)

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novartis
• Treatments: Fingolimod Hydrochloride

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.