Efficacy and Safety Study of MCI-186 for Treatment of the Patients With Amyotrophic Lateral Sclerosis (ALS) 2

NCT01492686 Phase 3 COMPLETED Results posted

The primary objective of the study is to confirm the efficacy of 60 mg of MCI-186 via intravenous drip infusion once a day in the patients with ALS based on the changes in the revised ALS functional rating scale (ALSFRS-R) scores after 24 weeks administration in double-blind, placebo-controlled manner. The study is also to examine the safety of MCI-186 to the ALS patients.

Details

Lead sponsor	Tanabe Pharma Corporation
Phase	Phase 3
Status	COMPLETED
Enrolment	137
Start date	2011-12
Completion	2014-10

Conditions

• Amyotrophic Lateral Sclerosis (ALS)

Interventions

• MCI-186
• Placebo
• MCI-186 in open label phase

Primary outcomes

• Change From Baseline in Revised ALS Functional Rating Scale (ALSFRS-R) Score in Full Analysis Set (FAS) Population at 24 Weeks — baseline and 24 weeks
  0=worst; 48=best

Countries

Japan