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

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: August 22, 2016
Last verified: August 2016
  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
Multiple Sclerosis
Drug: Ponesimod 10 mg
Drug: Ponesimod 20 mg
Drug: Ponesimod 40 mg
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 ]
    IMPORTANT NOTE: Only exploratory analyses will be performed.

  • Time to first confirmed relapse [ Time Frame: 240 weeks ] [ Designated as safety issue: No ]
    IMPORTANT NOTE: Only exploratory analyses will be performed.

  • Time to 3 month confirmed disability progression up to end of the study [ Time Frame: Estimated period of time over which the event is assessed: 3 months. The time to event is defined as the time from initiation of study treatment until the first EDSS assessment meeting the criteria for disability progression. ] [ Designated as safety issue: No ]
    IMPORTANT NOTE: Only exploratory analyses will be performed. Disability progression is defined as an increase of at least one full point in the Expanded Disability Status Scale (EDSS) score (or 1.5 points if the baseline EDSS was 0, or 0.5 points if the baseline EDSS was equal or greater than 5.5) with or without relapse, confirmed at the next scheduled EDSS assessment at least 12 weeks later (or if missing, at the next available scheduled EDSS assessment).

  • Time to 6 month confirmed disability progression up to end of the study [ Time Frame: Estimated period of time over which the event is assessed: 6 months. The time to event is defined as the time from initiation of study treatment until the first EDSS assessment meeting the criteria for disability progression. ] [ Designated as safety issue: No ]
    IMPORTANT NOTE: Only exploratory analyses will be performed. Disability progression is defined as an increase of at least one full point in the Expanded Disability Status Scale (EDSS) score (or 1.5 points if the baseline EDSS was 0, or 0.5 points if the baseline EDSS was equal or greater than 5.5) with or without relapse, confirmed at the next scheduled EDSS assessment at least 12 weeks later (or if missing, at the next available scheduled EDSS assessment).


Other Outcome Measures:
  • (Serious) Adverse Events [ Time Frame: Through study completion, for approx. 10 years: during Treatment Period (incl. Transition), i.e. study drug administration plus 7 days, and during the Follow up, i.e. from 8 until 30 days (Period 1) or until 90 days (Period 2) after study drug discontin. ] [ Designated as safety issue: Yes ]

Enrollment: 353
Study Start Date: May 2010
Estimated Study Completion Date: January 2022
Estimated Primary Completion Date: December 2021 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Ponesimod 10 mg
Ponesimod 10 mg oral use
Drug: Ponesimod 10 mg
Ponesimod 10 mg oral use
Experimental: Ponesimod 20 mg
Ponesimod 20 mg oral use
Drug: Ponesimod 20 mg
Ponesimod 20 mg oral use
Experimental: Ponesimod 40 mg
Ponesimod 40 mg oral use
Drug: Ponesimod 40 mg
Ponesimod 40 mg oral use

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years   (Adult)
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 81 Study Locations
Sponsors and Collaborators
Actelion
  More Information

Responsible Party: Actelion
ClinicalTrials.gov Identifier: NCT01093326     History of Changes
Other Study ID Numbers: AC-058B202 
Study First Received: March 24, 2010
Last Updated: August 22, 2016
Health Authority: Finland: Ethics Committee
Spain: Comité Ético de Investigación Clínica
United Kingdom: Research Ethics Committee
Poland: Ethics Committee
Switzerland: Swissmedic
United States: Food and Drug Administration
Czech Republic: State Institute for Drug Control
Finland: Finnish Medicines Agency
Germany: Ethics Commission
Austria: Ethikkommission
Romania: Ethics Committee
Russia: Ministry of Health of the Russian Federation
Germany: Federal Institute for Drugs and Medical Devices
Russia: Ethics Committee
Canada: Ethics Review Committee
France: Agence Nationale de Sécurité du Médicament et des produits de santé
Poland: The Central Register of Clinical Trials
Italy: Ethics Committee
Serbia: Ethics Committee
Hungary: National Institute of Pharmacy
Netherlands: Independent Ethics Committee
Ukraine: Ethics Committee
Sweden: Regional Ethical Review Board
Ukraine: State Pharmacological Center - Ministry of Health
Serbia and Montenegro: Agency for Drugs and Medicinal Devices
Hungary: Research Ethics Medical Committee
Israel: Ministry of Health
Netherlands: Medical Ethics Review Committee (METC)
Italy: The Italian Medicines Agency
Sweden: Medical Products Agency
Romania: National Medicines Agency
United States: Institutional Review Board
Bulgaria: Bulgarian Drug Agency
Spain: Agencia Española de Medicamentos y Productos Sanitarios
Austria: Federal Office for Safety in Health Care
Spain: Ethics Committee
Czech Republic: Ethics Committee
Switzerland: Ethikkommission
France: Committee for the Protection of Personnes
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
Bulgaria: Ethics committee
United Kingdom: Medicines and Healthcare Products Regulatory Agency
Canada: Health Canada

Additional relevant MeSH terms:
Sclerosis
Multiple Sclerosis
Multiple Sclerosis, Relapsing-Remitting
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on September 23, 2016