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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 : July 8, 2020
Sponsor:
Information provided by (Responsible Party):
Actelion

Tracking Information
First Submitted Date  ICMJE March 24, 2010
First Posted Date  ICMJE March 25, 2010
Last Update Posted Date July 8, 2020
Actual Study Start Date  ICMJE May 12, 2010
Estimated Primary Completion Date December 15, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 20, 2020)
  • Annualized confirmed relapse rate [ Time Frame: Up to 660 weeks (core plus extension) ]
    IMPORTANT NOTE: Only exploratory analyses will be performed.
  • Time to first confirmed relapse [ Time Frame: Up to 660 weeks (core plus extension) ]
    IMPORTANT NOTE: Only exploratory analyses will be performed.
  • 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.
Original Primary Outcome Measures  ICMJE
 (submitted: March 24, 2010)
  • Annualized confirmed relapse rate. [ Time Frame: 96 weeks ]
  • Time to first confirmed relapse [ Time Frame: 96 weeks ]
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures
 (submitted: May 20, 2020)
(Serious) Adverse Events [ Time Frame: Up to 660 weeks (core plus extension) ]
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Clinical Study to Investigate the Long-term Safety, Tolerability, and Efficacy of Ponesimod in Patients With Relapsing-remitting Multiple Sclerosis
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Multiple Sclerosis
Intervention  ICMJE
  • Drug: Ponesimod 10 mg
    Ponesimod 10 mg oral use
  • Drug: Ponesimod 20 mg
    Ponesimod 20 mg oral use
  • Drug: Ponesimod 40 mg
    Ponesimod 40 mg oral use
Study Arms  ICMJE
  • Experimental: Ponesimod 10 mg
    Ponesimod 10 mg oral use
    Intervention: Drug: Ponesimod 10 mg
  • Experimental: Ponesimod 20 mg
    Ponesimod 20 mg oral use
    Intervention: Drug: Ponesimod 20 mg
  • Experimental: Ponesimod 40 mg
    Ponesimod 40 mg oral use
    Intervention: Drug: Ponesimod 40 mg
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: April 18, 2012)
353
Original Estimated Enrollment  ICMJE
 (submitted: March 24, 2010)
320
Estimated Study Completion Date  ICMJE December 15, 2021
Estimated Primary Completion Date December 15, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Austria,   Bulgaria,   Canada,   Czechia,   Finland,   France,   Germany,   Hungary,   Israel,   Italy,   Netherlands,   Poland,   Romania,   Russian Federation,   Serbia,   Spain,   Sweden,   Switzerland,   Ukraine,   United Kingdom,   United States
Removed Location Countries Czech Republic
 
Administrative Information
NCT Number  ICMJE NCT01093326
Other Study ID Numbers  ICMJE AC-058B202
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Actelion
Study Sponsor  ICMJE Actelion
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Actelion
Verification Date July 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP