CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 181 enrolled
Drug / intervention
MCI-186 +1 moredrug
Likely dose
MCI-186 60 mg IV daily for 10 days per 14-day cycle, repeated 8 timesAI-extracted
Key inclusion· 1
  • ✓Completed drug administration without discontinuation in the preceding confirmatory study NCT00330681
Key exclusion· 5
  • ✕Severe complications including Parkinson's disease, schizophrenia, dementia, renal failure, or other severe complication
  • ✕History of hypersensitivity to edaravone
  • ✕Creatinine clearance ≤50 mL/min at completion of drug administration in study NCT00330681
  • ✕Pregnant, lactating, or planning to become pregnant; unable to agree to contraception

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

In the news

10 articles

Matched to this trial by ClinicalIndexfrom reputable biotech & medical press.

Search/NCT00424463
NCT00424463Phase 3Completed
CompareCT.gov

An Expanded Controlled Study of MCI-186 for Treatment of Amyotrophic Lateral Sclerosis in Double-Blind, Parallel-Group, Placebo-Controlled Manner (Phase 3)

Tanabe Pharma Corporation·interventional·Posted Jan 19, 2007·Updated Jan 6, 2026

In Brief

A Phase 3 clinical trial evaluating MCI-186 and Placebo of MCI-186 for Amyotrophic Lateral Sclerosis (ALS). Completed, enrolled 181 participants across 1 site.

Detailed Summary

This is a long-term, double-blind, placebo-controlled study of MCI-186 to treat ALS. This study is the long-term extension of Study NCT00330681; Study NCT00330681 is a Phase 3, randomized, double-blind, placebo control, parallel assignment, 24-week study in the treatment of ALS. The objectives of this study are to assess the efficacy and safety of long-term intermittent therapy with 60 mg MCI-186 to ALS patients.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAmyotrophic Lateral Sclerosis (ALS)
CountriesJapan
Collaborators--

Timeline

Phase 3CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJan 19, 2007
Enrollment StartJan 1, 2007
Primary CompletionMay 1, 2009
TodayJul 2, 2026
Enrollment to primary: 2.3 yearsPosted 19.5 years ago

Interventions

MCI-186drug

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.

Placebo of MCI-186drug

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.