NCT01226745

Phase 2 Extension Trial in Patients With Relapsing-Remitting Multiple Sclerosis (RRMS)

A Safety and Efficacy Extension Study of ONO-4641 (MSC2430913A) in Patients With Relapsing-Remitting Multiple Sclerosis

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 340 (actual)
• Sponsor: EMD Serono · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Not accepted

Summary

The objective of this active-drug Extension Study is to evaluate the continuing safety and efficacy of ONO-4641 (MSC2430913A) in subjects with relapsing-remitting multiple sclerosis (RRMS) who have completed an initial 26-week Core Study (ONO-4641POU006 \[NCT01081782\]).

Conditions

• Multiple Sclerosis

Interventions

Type	Name	Description
DRUG	ONO-4641	Subjects will be administered with ONO-4641 at a dose of 0.15 milligram (mg) in the core study will be administered with ONO-4641 0.15 mg in this extension study for a duration of 225 weeks.
DRUG	ONO-4641	Subjects will be administered with ONO-4641 at a dose of 0.10 mg in the core study will be administered with ONO-4641 0.10 mg in this extension study for a duration of 225 weeks.
DRUG	ONO-4641	Subjects will be administered with ONO-4641 at a dose of 0.05 mg in the core study will be administered with ONO-4641 0.05 mg in this extension study for a duration of 225 weeks.
DRUG	ONO-4641	Subjects will receive placebo in the core study will be administered with ONO-4641 0.15 mg in this extension study for a duration of 225 weeks.
DRUG	ONO-4641	Subjects will receive placebo in the core study will be administered with ONO-4641 0.10 mg in this extension study for a duration of 225 weeks.
DRUG	ONO-4641	Subjects will receive placebo in the core study will be administered with ONO-4641 0.05 mg in this extension study for a duration of 225 weeks.

Timeline

• Start date: 2010-10-01
• Primary completion: 2015-01-01
• Completion: 2015-01-01
• First posted: 2010-10-22
• Last updated: 2016-07-12
• Results posted: 2016-07-12

Locations

70 sites across 11 countries: United States, Belgium, Canada, Czechia, Germany, Greece, Japan, Poland, Russia, Spain, Ukraine