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

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

Quick Info:

Status:
This study has been completed
Estimated Enrollment:
128
Phase:
III
Treatment Type:
Injection
Trial Type:
Double-blind placebo
Sponsor:
Mitsubishi Tanabe Pharma Corporation
Primary Investigator:
Contact Information:
    Contact information unknown.

Enrollment Criteria:

Forced Ventilation

Breathing Ability

Percent lung function (FVC) or (SVC)
N/A
Months/Onset

Months Since Onset

Number of months since first
symptoms of ALS
<24
BiPap Allowed

Non-Invasive Ventilation (NIV)

Can PALS use a BiPAP in the trial?
Unknown
DPS Allowed

Diaphragm Pacer (DPS)

Can PALS use a DPS in the trial?
Unknown
Edaravone Usage

Edaravone Usage

Can a PALS use edaravone (Radicut/Radicava)
while enrolled in the trial?
Unknown

Update Notes:

6/23/2015Trial completed.
8/25/2014No significant updates.
8/7/2013This study is active, but not currently recruiting.
3/27/2013Enrollment criteria added.
2/28/2013Clinical trial added.

Locations:

Japan

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):
News Articles and Summaries:
ALS Forum:
First Published on Clinicaltrials.gov: 12/11/2011
ClinicalTrials.gov ID: NCT01492686
Trial Protocol as Published on Clinicaltrials.gov:
ClinicalTrials.gov