Other Information
Purpose
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.
Eligibility
Both gender 20-75. “Definite ALS” or “probable ALS” diagnosis. Can eat a meal, excrete, move alone. Less than 2 years after onset. Exclusion: Parkinson's disease, schizophrenia, dementia, renal failure, or other severe complication, anamnesis of hypersensitivity to edaravone. Pregnancy or lactation, participation in other trials within 12 weeks.
Details
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 Protocol as Published on Clinicaltrials.gov