Phase 3 Study of MCI-186 for Treatment of Amyotrophic Lateral Sclerosis

PHASE3CompletedINTERVENTIONAL
Enrollment

137

Participants

Timeline

Start Date

December 31, 2011

Primary Completion Date

September 30, 2014

Study Completion Date

October 31, 2014

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). The following treatment (10 days' administration during 14 days) - observation (14 days) cycle is repeated five times (2nd-6th cycles).

DRUG

Placebo

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

DRUG

MCI-186 in open label phase

All patients after the double blind phase may receive MCI-186 in 7th until 12th treatment - observation cycles at the patients' will.

Trial Locations (1)

Unknown

Osaka

All Listed Sponsors
lead

Mitsubishi Tanabe Pharma Corporation

INDUSTRY