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

Actelion Pharmaceuticals

Status and phase: Completed; Phase 2

Conditions: Multiple Sclerosis

Treatments: Drug: Ponesimod 20 mg; Drug: Ponesimod 40 mg; Drug: Ponesimod 10 mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT01093326

2009-011470-15 (EudraCT Number)

AC-058B202

Details and patient eligibility

About

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.

Enrollment: 353 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Patients who completed study treatment at their regular Week 24 (End of treatment) visit within the core study AC-058B201.
2. Signed informed consent for participating in the extension study.

Exclusion criteria

1. Any clinically relevant medical or surgical condition, which, in the opinion of the investigator, would put the patient at risk by participating in the extension study.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

353 participants in 3 patient groups

Ponesimod 10 mg

Experimental group

Description:

Ponesimod 10 mg oral use

Treatment:

Drug: Ponesimod 10 mg

Ponesimod 20 mg

Experimental group

Description:

Ponesimod 20 mg oral use

Treatment:

Drug: Ponesimod 20 mg

Ponesimod 40 mg

Experimental group

Description:

Ponesimod 40 mg oral use

Treatment:

Drug: Ponesimod 40 mg