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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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23 October 2023 |
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Main ID: |
NCT01093326 |
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Date of registration:
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24/03/2010 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Clinical Study to Investigate the Long-term Safety, Tolerability, and Efficacy of Ponesimod in Patients With Relapsing-remitting Multiple Sclerosis
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Scientific title:
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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 |
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Date of first enrolment:
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May 12, 2010 |
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Target sample size:
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353 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/ct2/show/NCT01093326 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
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Phase:
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Phase 2
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Countries of recruitment
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Austria
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Bulgaria
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Canada
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Czech Republic
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Czechia
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Finland
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France
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Germany
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Hungary
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Israel
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Italy
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Netherlands
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Poland
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Romania
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Russian Federation
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Serbia
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Spain
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Sweden
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Switzerland
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Ukraine
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United Kingdom
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United States
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Key inclusion & exclusion 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.
Age minimum:
18 Years
Age maximum:
55 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Multiple Sclerosis
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Intervention(s)
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Drug: Ponesimod 40 mg
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Drug: Ponesimod 20 mg
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Drug: Ponesimod 10 mg
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Primary Outcome(s)
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Time to 24 Weeks Confirmed Disability Progression up to end of the study
[Time Frame: Up to 660 weeks (core plus extension)]
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Annualized confirmed relapse rate
[Time Frame: Up to 660 weeks (core plus extension)]
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Time to first confirmed relapse
[Time Frame: Up to 660 weeks (core plus extension)]
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Secondary ID(s)
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AC-058B202
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2009-011470-15
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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