An international study, which is an extension to protocol AC 058B201, with the aim to study how safe and efficacious is the long-term treatment with ponesimod in three different doses in patients with relapsing-remitting multiple sclerosis.

Phase 1

• Conditions: relapsing-remitting multiple sclerosis; MedDRA version: 21.1Level: PTClassification code 10063399Term: Relapsing-remitting multiple sclerosisSystem Organ Class: 10029205 - Nervous system disorders; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: EUCTR2009-011470-15-PL
• Lead Sponsor: ACTELION Pharmaceuticals Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2010-05-25
• Last Update Posted: 28 August 2023

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 353

Inclusion Criteria

1. Patients who completed study treatment at their regular Week 24 (EOT) visit within the core study (AC-058B201).

2. Signed informed consent for participating in the extension study.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 353
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. Patients meeting any of the study-specific criteria for permanent discontinuation of study drug, or patients receiving any of the prohibited concomitant medication.

2. Any other 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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: All objectives for this study are exploratory:<br><br>- To investigate the long-term safety and tolerability of ponesimod.<br>- To investigate the long-term efficacy of ponesimod.<br>- To explore the dose response relationship of 10, 20 and 40 mg<br>ponesimod on lymphocyte count, MRI endpoints, annualized relapse rate (ARR), and safety endpoints.;Secondary Objective: Not applicable;Primary end point(s): Only exploratory efficacy endpoints will be investigated.<br><br>The following exploratory endpoints will be analyzed:<br>1. Annualized confirmed relapse rate.<br>2. Time to first confirmed relapse<br>3. Time to 24-week confirmed disability progression up to end of the study.<br><br>Additional endpoints/parameters based on MRI scans, relapses as well as endpoints related to safety and tolerability will be investigated.<br>;Timepoint(s) of evaluation of this end point: Not applicable

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Not applicable;Timepoint(s) of evaluation of this end point: Not applicable