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

NCT ID: NCT01093326

Last Updated: 2025-03-30

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

353 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-05-12

Study Completion Date

2023-09-06

Brief Summary

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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.

Detailed Description

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Conditions

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Multiple Sclerosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Ponesimod 10 mg

Ponesimod 10 mg oral use

Group Type EXPERIMENTAL

Ponesimod 10 mg

Intervention Type DRUG

Ponesimod 10 mg oral use

Ponesimod 20 mg

Ponesimod 20 mg oral use

Group Type EXPERIMENTAL

Ponesimod 20 mg

Intervention Type DRUG

Ponesimod 20 mg oral use

Ponesimod 40 mg

Ponesimod 40 mg oral use

Group Type EXPERIMENTAL

Ponesimod 40 mg

Intervention Type DRUG

Ponesimod 40 mg oral use

Interventions

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Ponesimod 10 mg

Ponesimod 10 mg oral use

Intervention Type DRUG

Ponesimod 20 mg

Ponesimod 20 mg oral use

Intervention Type DRUG

Ponesimod 40 mg

Ponesimod 40 mg oral use

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Actelion

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Phoenix, Arizona, United States

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Scottsdale, Arizona, United States

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Palo Alto, California, United States

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Sacramento, California, United States

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Venice, Florida, United States

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Indianapolis, Indiana, United States

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Kansas City, Kansas, United States

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Lenexa, Kansas, United States

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Latham, New York, United States

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Schenectady, New York, United States

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Stony Brook, New York, United States

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Raleigh, North Carolina, United States

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Cincinnati, Ohio, United States

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Columbus, Ohio, United States

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Burlington, Vermont, United States

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Kirkland, Washington, United States

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Vienna, , Austria

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Sofia, , Bulgaria

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Ottawa, Ontario, Canada

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Brno, , Czechia

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Jihlava, , Czechia

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Olomouc, , Czechia

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Ostrava-Poruba, , Czechia

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Prague, , Czechia

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Teplice, , Czechia

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Helsinki, , Finland

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Hyvinkää, , Finland

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Tampere, , Finland

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Turku, , Finland

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Montpellier, , France

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Berlin, , Germany

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Essen, , Germany

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Ulm, , Germany

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Budapest, , Hungary

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Esztergom, , Hungary

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Győr, , Hungary

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Miskolc, , Hungary

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Tel Litwinsky, , Israel

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Ẕerifin, , Israel

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Breda, , Netherlands

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Katowice, , Poland

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Poznan, , Poland

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Warsaw, , Poland

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Wroclaw, , Poland

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Cluj-Napoca, , Romania

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Timișoara, , Romania

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Kazan', , Russia

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Moscow, , Russia

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Nizhny Novgorod, , Russia

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Pyatigorsk, , Russia

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Saint Petersburg, , Russia

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Samara, , Russia

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Saratov, , Russia

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Ufa, , Russia

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Belgrade, , Serbia

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Kragujevac, , Serbia

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Niš, , Serbia

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Majadahonda, , Spain

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Málaga, , Spain

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Seville, , Spain

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Gothenburg, , Sweden

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Stockholm, , Sweden

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Umeå, , Sweden

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Lugano, , Switzerland

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Chernihiv, , Ukraine

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Dnipropetrovsk, , Ukraine

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Kyiv, , Ukraine

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Odesa, , Ukraine

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Bristol, , United Kingdom

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London, , United Kingdom

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Plymouth, , United Kingdom

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Countries

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United States Austria Bulgaria Canada Czechia Finland France Germany Hungary Israel Netherlands Poland Romania Russia Serbia Spain Sweden Switzerland Ukraine United Kingdom

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

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2009-011470-15

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

AC-058B202

Identifier Type: -

Identifier Source: org_study_id

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