Trial: Phase 3 Study of MCI-186 for Treatment of Amyotrophic Lateral Sclerosis

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Quick Info

Status

This study has been completed

Phase

Trial Type

Double-blind placebo

Treatment Type

Injection

Randomization

Unknown

Enrollment

128

Start Date

12/1/2011

Sponsor

Mitsubishi Tanabe Pharma Corporation

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

Open Label

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)