Extension study for S1P1 agonist in Multiple Sclerosis

• Research type

  Research Study

• Full title

  Multicenter, randomized, double-blind, parallel-group extension to study AC 058B201 to investigate the long-term safety, tolerability, and efficacy of 10, 20, and 40 mg/day ACT-128800, an oral S1P1 receptor agonist, in patients with relapsing-remitting multiple sclerosis.

• IRAS ID

  48410

• Contact name

  David Cottrell

• Sponsor organisation

  Actelion Pharmaceuticals Ltd

• Eudract number

  2009-011470-15

• Research summary

  This is a prospective, multicenter, multinational, randomized, double-blind, multiple-dose, uncontrolled, parallel group extension study in patients with relapsing-remitting multiple sclerosis (RRMS), for subjects who have completed their regular Week 24, end of treatment (EOT) visit of the core study (AC-058B201) while on study treatment. The study is designed to investigate the long-term safety, tolerability, and efficacy of three doses of ACT-128800 administered for up to 120 weeks (24 weeks of treatment during core study, up to 96 weeks of treatment during extension study). After a transition period of up to 3 days, patients having received treatment with ACT 128800 (10, 20, or 40 mg) during the core study (AC-058B201) will continue their treatment on the same dose in this extension study. Patients having received placebo in the core study will be randomized 1:1:1 to 10, 20, or 40 mg ACT-128800. It is planned that there will be approximately 120 centres in approximately 20 countries. The number of subjects included will depend on the number of subjects who complete their regular week-24 (end of treatment) visit in the core study (AC-058B201) while on study treatment and who decide to participate in this extension study.

• REC name

  North West - Liverpool Central Research Ethics Committee

• REC reference

  10/H1002/29

• Date of REC Opinion

  22 Jun 2010

• REC opinion

  Further Information Favourable Opinion