Ponesimod in Patients With Relapsing-remitting Multiple Sclerosis -Extension Study

This study is ongoing, but not recruiting participants.

Sponsor:

Information provided by (Responsible Party):

Actelion

ClinicalTrials.gov Identifier:

NCT01093326

First received: March 24, 2010

Last updated: October 8, 2012

Last verified: October 2012

History of Changes

Purpose

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.

Condition	Intervention	Phase
Relapsing-remitting Multiple Sclerosis	Drug: Ponesimod	Phase 2

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	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

Resource links provided by NLM:

Genetics Home Reference related topics: multiple sclerosis

MedlinePlus related topics: Multiple Sclerosis

U.S. FDA Resources

Further study details as provided by Actelion:

Primary Outcome Measures:

Annualized confirmed relapse rate. [ Time Frame: 240 weeks ] [ Designated as safety issue: No ]
Time to first confirmed relapse [ Time Frame: 240 weeks ] [ Designated as safety issue: No ]

Enrollment:	353
Study Start Date:	May 2010
Estimated Study Completion Date:	July 2016
Estimated Primary Completion Date:	March 2016 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Investigational Drug - Dose 1	Drug: Ponesimod Ponesimod 10 mg
Experimental: Investigational Drug Dose 2	Drug: Ponesimod Ponesimod 20 mg
Experimental: Investigational Drug - Dose 3	Drug: Ponesimod Ponesimod 40 mg

Eligibility

Ages Eligible for Study:	18 Years to 55 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01093326

Show 83 Study Locations

Sponsors and Collaborators

Actelion

Investigators

Study Director:

Actelion Pharmaceuticals

Actelion

More Information

No publications provided

Responsible Party:	Actelion
ClinicalTrials.gov Identifier:	NCT01093326 History of Changes
Other Study ID Numbers:	AC-058B202
Study First Received:	March 24, 2010
Last Updated:	October 8, 2012
Health Authority:	Austria: Federal Office for Safety in Health Care Austria: Ethikkommission Bulgaria: Bulgarian Drug Agency Bulgaria: Ethics committee Canada: Ethics Review Committee Canada: Health Canada Czech Republic: Ethics Committee Czech Republic: State Institute for Drug Control Finland: Ethics Committee Finland: Finnish Medicines Agency France: L’Agence nationale de sécurité du médicament et des produits de santé France: Committee for the Protection of Personnes Germany: Ethics Commission Germany: Federal Institute for Drugs and Medical Devices Hungary: National Institute of Pharmacy Hungary: Research Ethics Medical Committee Israel: Ministry of Health Italy: Ethics Committee Italy: The Italian Medicines Agency Netherlands: Independent Ethics Committee Netherlands: Medical Ethics Review Committee (METC) Netherlands: The Central Committee on Research Involving Human Subjects (CCMO) Poland: Ethics Committee Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products Poland: The Central Register of Clinical Trials Romania: Ethics Committee Romania: National Medicines Agency Russia: Ethics Committee Russia: Ministry of Health of the Russian Federation Serbia and Montenegro: Agency for Drugs and Medicinal Devices Serbia: Ethics Committee Spain: Agencia Española de Medicamentos y Productos Sanitarios Spain: Comité Ético de Investigación Clínica Spain: Ethics Committee Sweden: Medical Products Agency Sweden: Regional Ethical Review Board Switzerland: Ethikkommission Switzerland: Swissmedic Ukraine: Ethics Committee Ukraine: State Pharmacological Center - Ministry of Health United Kingdom: Medicines and Healthcare Products Regulatory Agency United Kingdom: Research Ethics Committee United States: Food and Drug Administration United States: Institutional Review Board

Additional relevant MeSH terms:

Multiple Sclerosis
Sclerosis
Multiple Sclerosis, Relapsing-Remitting
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System

Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on May 19, 2013

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