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

PHASE3CompletedINTERVENTIONAL
Enrollment

206

Participants

Timeline

Start Date

May 31, 2006

Primary Completion Date

September 30, 2008

Study Completion Date

September 30, 2008

Conditions
Amyotrophic Lateral Sclerosis (ALS)
Interventions
DRUG

MCI-186

Two ampoules (60 mg) of MCI-186 injection are intravenously administered once a day, for successive 14 days, followed by 14 days observation period (first cycle). Then treatment (10 days' administration during 14 days) - observation (14 days) cycle is repeated five times (2nd-6th cycles).

DRUG

Placebo of MCI-186

Two ampoules of placebo injection are intravenously administered once a day, for successive 14 days, followed by 14 days observation period (first cycle). Then treatment (10 days' administration during 14 days) - observation (14 days) cycle is repeated five times (2nd-6th cycles).

All Listed Sponsors
lead

Mitsubishi Tanabe Pharma Corporation

INDUSTRY