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A Study in Patients With Amyotrophic Lateral Sclerosis (ALS)

NCT00444613 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 373

Last updated 2023-06-18

No results posted yet for this study

Summary

The purpose of this study is to investigate the efficacy and confirm the safety of E0302 in patients with Amyotrophic Lateral Sclerosis (ALS) by assessing changes in scores of survival rate and functional rating scale.

Conditions

  • Amyotrophic Lateral Sclerosis (ALS)

Interventions

DRUG

E0302 (mecobalamin)

Intramuscular injection, mecobalamin 25 mg twice a week for 3.5 years.

DRUG

E0302 (mecobalamin)

Intramuscular injection, mecobalamin 50 mg twice a week for 3.5 years.

DRUG

Placebo

Intramuscular injection, placebo twice a week for 3.5 years.

Sponsors & Collaborators

  • Eisai Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Kazunori Saeki · Neuroscience Clinical Development Section. JAC PCU. Eisai Co., Ltd.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-04-30
Primary Completion
2014-03-31
Completion
2014-07-31

Countries

  • Japan

Study Locations

More Related Trials

Entities

Drugs

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 NCT00444613 on ClinicalTrials.gov