Clinical Study to Evaluate the Efficacy, Safety, and Tolerability of ACT-128800 in Patients With Relapsing-remitting Multiple Sclerosis
Summary
This study will assess the efficacy, safety, and tolerability of ACT-128800 in patients with relapsing-remitting multiple sclerosis.
Timeline
- Start
- 2009-10-01
- Primary completion
- 2011-06-01
- Completion
- 2011-07-01
Outcome
Met primary endpoint
registry analysis (superiority test); Ponesimod 40 mg vs Placebo; p <0.0001; Treatment effect (rate ratio) 0.226 (95% CI 0.133 to 0.384) NCT01006265 ↗
registry analysis (superiority test); Ponesimod 20 mg vs Placebo; p <0.0001; Treatment effect (rate ratio) 0.170 (95% CI 0.100 to 0.289) NCT01006265 ↗
registry analysis (superiority test); Ponesimod 10 mg vs Placebo; p = 0.0318; Treatment effect (rate ratio) 0.566 (95% CI 0.337 to 0.952) NCT01006265 ↗
paper The mean cumulative number of new T1 Gd+ lesions at weeks 12-24 was significantly lower in the ponesimod 10 mg PMID 24659797 ↗
Publications
- Results Olsson T, Boster A, Fernandez O, Freedman MS, Pozzilli C, Bach D, Berkani O, Mueller MS, Sidorenko T, Radue EW, Melanson M. Oral ponesimod in relapsing-remitting multiple sclerosis: a randomised phase II trial. J Neurol Neurosurg Psychiatry. 2014 Nov;85(11):1198-208. doi: 10.1136/jnnp-2013-307282. Epub 2014 Mar 21.
- Gisleskog PO, Valenzuela B, Scherz T, Burcklen M, Perez-Ruixo JJ, Poggesi I. An Exposure-Response Analysis of the Clinical Efficacy of Ponesimod in a Randomized Phase II Study in Patients with Multiple Sclerosis. Clin Pharmacokinet. 2021 Sep;60(9):1227-1237. doi: 10.1007/s40262-021-01020-2. Epub 2021 Apr 29.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Ponesimod | Small molecule | 10 mg | Oral |
| Subject | Ponesimod | Small molecule | 20 mg | Oral |
| Subject | Ponesimod | Small molecule | 40 mg | Oral |