NCT01093326

Clinical Study to Investigate the Long-term Safety, Tolerability, and Efficacy of Ponesimod in Patients With Relapsing-remitting Multiple Sclerosis

Multicenter, Randomized, Double-blind, Parallel-group Extension to Study AC-058B201 to Investigate the Long-term Safety, Tolerability, and Efficacy of Three Doses of Ponesimod, an Oral S1P1 Receptor Agonist, in Patients With Relapsing-remitting Multiple Sclerosis

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 353 (actual)
• Sponsor: Actelion · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Not accepted

Summary

This study is an extension to the study AC-058B201 and will investigate the long-term safety, tolerability and efficacy of ponesimod in patients with relapsing-remitting multiple sclerosis.

Conditions

• Multiple Sclerosis

Interventions

Type	Name	Description
DRUG	Ponesimod 10 mg	Ponesimod 10 mg oral use
DRUG	Ponesimod 20 mg	Ponesimod 20 mg oral use
DRUG	Ponesimod 40 mg	Ponesimod 40 mg oral use

Timeline

• Start date: 2010-05-12
• Primary completion: 2023-09-06
• Completion: 2023-09-06
• First posted: 2010-03-25
• Last updated: 2025-03-30
• Results posted: 2024-10-01

Locations

71 sites across 20 countries: United States, Austria, Bulgaria, Canada, Czechia, Finland, France, Germany, Hungary, Israel, Netherlands, Poland, Romania, Russia, Serbia, Spain, Sweden, Switzerland, Ukraine, United Kingdom