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
  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:


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:

  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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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: 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 July 20, 2014