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Expanded Controlled Study of Safety and Efficacy of MCI-186 in Patients With Amyotrophic Lateral Sclerosis (ALS)

NCT00424463 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 181

Last updated 2026-01-06

Study results available
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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.

Conditions

  • Amyotrophic Lateral Sclerosis (ALS)

Interventions

DRUG

MCI-186

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.

DRUG

Placebo of MCI-186

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.

Sponsors & Collaborators

  • Tanabe Pharma Corporation

    lead INDUSTRY

Principal Investigators

  • Koji Abe, professor · Graduate School of Medicine and Dentistry, Okayama University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-01-31
Primary Completion
2009-05-31
Completion
2009-05-31

Countries

  • Japan

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00424463 on ClinicalTrials.gov