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 9, 2015
Last verified: October 2015

March 24, 2010
October 9, 2015
May 2010
December 2021   (final data collection date for primary outcome measure)
  • 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).
  • Annualized confirmed relapse rate. [ Time Frame: 96 weeks ] [ Designated as safety issue: No ]
  • Time to first confirmed relapse [ Time Frame: 96 weeks ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01093326 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
(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 ]
Not Provided
 
Ponesimod in Patients With Relapsing-remitting Multiple Sclerosis -Extension Study
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
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.
Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Relapsing-remitting Multiple Sclerosis
  • 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
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
353
January 2022
December 2021   (final data collection date for primary outcome measure)

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.

Both
18 Years to 55 Years
No
Contact information is only displayed when the study is recruiting subjects
United States,   Austria,   Bulgaria,   Canada,   Czech Republic,   Finland,   France,   Germany,   Hungary,   Israel,   Italy,   Netherlands,   Poland,   Romania,   Russian Federation,   Serbia,   Spain,   Sweden,   Switzerland,   Ukraine,   United Kingdom
 
NCT01093326
AC-058B202
Yes
Not Provided
Not Provided
Actelion
Actelion
Not Provided
Not Provided
Actelion
October 2015

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