Conditions: Multiple Sclerosis
Keywords: Multiple sclerosis ONO-4641 MSC2430913A Efficacy
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 340
Healthy volunteers: no

Brief 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 \[NCT01081782\]).

Detailed description:

Arms:
arm 1: None arm 2: None arm 3: None arm 4: None arm 5: None arm 6: None

Interventions: intervention 1: ONO-4641 intervention 2: ONO-4641 intervention 3: ONO-4641 intervention 4: ONO-4641 intervention 5: ONO-4641 intervention 6: ONO-4641
Intervention descriptions: intervention 1: 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. intervention 2: 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. intervention 3: 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. intervention 4: 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. intervention 5: 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. intervention 6: 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.

Protocol document: