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Quick Info
Status
This study has been completed
Estimated Enrollment
128
Phase
3
Treatment Type
Injection
Trial Type
Double-blind placebo
Primary Investigator
Primary investigator not known.
Contact Information
    Contact information unknown.
Locations
Japan
Enrollment Criteria
Breathing Ability
Percent lung function (FVC) or (SVC)
N/A
Months Since Onset
Number of months since first symptoms of ALS.
<24
Non-Invasive Ventilation (NIV)
Can PALS use a BiPAP in the trial?
Unknown
Diaphragm Pacer (DPS)
Can PALS use a DPS in the trial?
Unknown
Edaravone Usage
Can a PALS use edaravone (Radicut/Radicava) while enrolled in the trial?
Unknown
Update Notes
Trial completed.
6/23/2015
No significant updates.
8/25/2014
This study is active, but not currently recruiting.
8/7/2013
Enrollment criteria added.
3/27/2013
Clinical trial added.
2/28/2013

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.
Collaborator(s)
    -
Trial Protocol as Published on Clinicaltrials.gov
NCT01492686 (First Published: 12/11/2011)