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 8, 2012
Last verified: October 2012

March 24, 2010
October 8, 2012
May 2010
March 2016   (final data collection date for primary outcome measure)
  • Annualized confirmed relapse rate. [ Time Frame: 240 weeks ] [ Designated as safety issue: No ]
  • Time to first confirmed relapse [ Time Frame: 240 weeks ] [ Designated as safety issue: No ]
  • 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
Not Provided
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
    Ponesimod 10 mg
  • Drug: Ponesimod
    Ponesimod 20 mg
  • Drug: Ponesimod
    Ponesimod 40 mg
  • Experimental: Investigational Drug - Dose 1
    Intervention: Drug: Ponesimod
  • Experimental: Investigational Drug Dose 2
    Intervention: Drug: Ponesimod
  • Experimental: Investigational Drug - Dose 3
    Intervention: Drug: Ponesimod
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
July 2016
March 2016   (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
Finland,   Serbia,   Bulgaria,   Czech Republic,   Israel,   Italy,   Poland,   Sweden,   United States,   Spain,   Austria,   Canada,   France,   Germany,   Hungary,   Netherlands,   Romania,   Switzerland,   United Kingdom,   Russian Federation,   Ukraine
 
NCT01093326
AC-058B202
Yes
Actelion
Actelion
Not Provided
Study Director: Actelion Pharmaceuticals Actelion
Actelion
October 2012

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