Expanded Controlled Study of Safety and Efficacy of MCI-186 in Patients With Amyotrophic Lateral Sclerosis (ALS)

PHASE3CompletedINTERVENTIONAL
Enrollment

181

Participants

Timeline

Start Date

January 31, 2007

Primary Completion Date

May 31, 2009

Study Completion Date

May 31, 2009

Conditions
Amyotrophic Lateral Sclerosis (ALS)
Interventions
DRUG

MCI-186

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

DRUG

Placebo of MCI-186

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

Trial Locations (1)

Unknown

National Hospital Organization Miyagi National Hospital, Watari-gun

All Listed Sponsors
lead

Mitsubishi Tanabe Pharma Corporation

INDUSTRY