NCT01006265

Clinical Study to Evaluate the Efficacy, Safety, and Tolerability of ACT-128800 in Patients With Relapsing-remitting Multiple Sclerosis

Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group, Dose-finding Study to Evaluate the Efficacy, Safety, and Tolerability of Three Doses of ACT-128800, an Oral S1P1 Receptor Agonist, Administered for Twenty-four Weeks in Patients With Relapsing-remitting Multiple Sclerosis

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 464 (actual)
• Sponsor: Actelion · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Not accepted

Summary

This study will assess the efficacy, safety, and tolerability of ACT-128800 in patients with relapsing-remitting multiple sclerosis.

Conditions

• Multiple Sclerosis

Interventions

Type	Name	Description
DRUG	ACT-128800 Dose 1	ACT-128800 (Dose 1) administered orally once daily
DRUG	Placebo	Matching placebo administered orally once daily
DRUG	ACT-128800 Dose 2	ACT-128800 (Dose 2) administered orally once daily
DRUG	ACT-128800 Dose 3	ACT-128800 (Dose 3) administered orally once daily

Timeline

• Start date: 2009-10-01
• Primary completion: 2011-06-01
• Completion: 2011-07-01
• First posted: 2009-11-02
• Last updated: 2025-03-30
• Results posted: 2021-06-11

Locations

115 sites across 23 countries: United States, Australia, Austria, Belgium, Bulgaria, Canada, Czechia, Finland, France, Germany, Hungary, Israel, Italy, Netherlands, Poland, Romania, Russia, Serbia, Spain, Sweden, Switzerland, Ukraine, United Kingdom

Regulatory

• FDA-regulated drug study