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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01093326
Recruitment Status : Active, not recruiting
First Posted : March 25, 2010
Last Update Posted : June 1, 2023
Sponsor:
Information provided by (Responsible Party):
Actelion

Study Description
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Brief Summary:
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 or disease Intervention/treatment Phase
Multiple Sclerosis Drug: Ponesimod 10 mg Drug: Ponesimod 20 mg Drug: Ponesimod 40 mg Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 353 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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
Actual Study Start Date : May 12, 2010
Estimated Primary Completion Date : September 6, 2023
Estimated Study Completion Date : September 6, 2023

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. Annualized confirmed relapse rate [ Time Frame: Up to 660 weeks (core plus extension) ]
    IMPORTANT NOTE: Only exploratory analyses will be performed.

  2. Time to first confirmed relapse [ Time Frame: Up to 660 weeks (core plus extension) ]
    IMPORTANT NOTE: Only exploratory analyses will be performed.

  3. Time to 24 Weeks Confirmed Disability Progression up to end of the study [ Time Frame: Up to 660 weeks (core plus extension) ]
    IMPORTANT NOTE: Only exploratory analyses will be performed. Disability progression is defined as an increase of at least one full point in the 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 24 weeks later (or if missing, at the next available scheduled EDSS assessment). 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.


Other Outcome Measures:
  1. (Serious) Adverse Events [ Time Frame: Up to 660 weeks (core plus extension) ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01093326


Locations
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Sponsors and Collaborators
Actelion
More Information
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Responsible Party: Actelion
ClinicalTrials.gov Identifier: NCT01093326    
Other Study ID Numbers: AC-058B202
2009-011470-15 ( EudraCT Number )
First Posted: March 25, 2010    Key Record Dates
Last Update Posted: June 1, 2023
Last Verified: May 2023
Additional relevant MeSH terms:
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Multiple Sclerosis
Multiple Sclerosis, Relapsing-Remitting
Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
 Autoimmune Diseases
Immune System Diseases
Ponesimod
Sphingosine 1 Phosphate Receptor Modulators
Molecular Mechanisms of Pharmacological Action
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs