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COMPLETED
NCT00330681
PHASE3

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

Sponsor: Shionogi

View on ClinicalTrials.gov

Summary

The primary objective of this study is to confirm the efficacy of 60 mg of MCI-186 via intravenous drip once a day in 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. And in addition, this study will be performed to examine the safety of MCI-186 to ALS patients.

Official title: A Confirmatory Study of MCI-186 for Treatment of Amyotrophic Lateral Sclerosis in Double-blind, Parallel-group, Placebo-controlled Manner.

Key Details

Gender

All

Age Range

20 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

206

Start Date

2006-05-31

Completion Date

2008-09-30

Last Updated

2026-07-21

Healthy Volunteers

No

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).