At a glance
ClinicalIndex Comparison Record- ✓Definite or probable ALS per El Escorial and revised Airlie House diagnostic criteria
- ✓Can eat, use toilet, and move independently without assistance in daily activities
- ✓Less than 2 years from ALS symptom onset
- ✓Disease progression documented during 12 weeks prior to enrollment
- ✕Comorbid Parkinson's disease, schizophrenia, dementia, renal failure, or other severe complications
- ✕Prior hypersensitivity to edaravone
- ✕Pregnant, lactating, or planning pregnancy; cannot agree to contraception
- ✕Participation in another clinical trial within 12 weeks prior to consent or ongoing participation in other trials
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Efficacy and Safety Study of MCI-186 for Treatment of the Patients With Amyotrophic Lateral Sclerosis (ALS) 2
In Brief
A Phase 3 clinical trial evaluating MCI-186, Placebo, and 1 other intervention for Amyotrophic Lateral Sclerosis (ALS). Completed, enrolled 137 participants across 1 site.
Detailed Summary
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.
Study Details
Timeline
Interventions
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).
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).
All patients after the double blind phase may receive MCI-186 in 7th until 12th treatment - observation cycles at the patients' will.