A Long-Term Study in Patients With Amyotrophic Lateral Sclerosis (ALS)

June 16, 2023 updated by: Eisai Co., Ltd.
The purpose of this study is to investigate the safety and efficacy of long-term E0302 administration in patients with Amyotrophic Lateral Sclerosis (ALS).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

135

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
    • Aichi
      • Nagoya-shi, Aichi, Japan
    • Aomori
      • Aomori-shi, Aomori, Japan
    • Chiba
      • Chiba-shi, Chiba, Japan
    • Ehime
      • Touon-shi, Ehime, Japan
    • Fukuoka
      • Fukuoka-shi, Fukuoka, Japan
      • Kitakyushi-shi, Fukuoka, Japan
    • Fukushima
      • Fukushima-shi, Fukushima, Japan
    • Gunma
      • Maebashi-shi, Gunma, Japan
    • Hiroshima
      • Higashihiroshima-shi, Hiroshima, Japan
      • Miyoshi-shi, Hiroshima, Japan
      • Otake-shi, Hiroshima, Japan
    • Hokkaido
      • Sapporo-shi, Hokkaido, Japan
    • Ishikawa
      • Kanazawa-shi, Ishikawa, Japan
    • Iwate
      • Ichinoseki-shi, Iwate, Japan
    • Kanagawa
      • Sagamihara-shi, Kanagawa, Japan
      • Yokohama-shi, Kanagawa, Japan
    • Kochi
      • Nangoku-shi, Kochi, Japan
    • Kyoto
      • Kyoto-shi, Kyoto, Japan
    • Mie
      • Tsu-shi, Mie, Japan
    • Miyagi
      • Sendai-shi, Miyagi, Japan
      • Watari-gun, Miyagi, Japan
    • Nagano
      • Nagano-shi, Nagano, Japan
    • Nagasaki
      • Higashisonogi-gun, Nagasaki, Japan
    • Niigata
      • Kashiwazaki-shi, Niigata, Japan
      • Niigata-shi, Niigata, Japan
    • Okayama
      • Tsukubo-gun, Okayama, Japan
    • Okinawa
      • Ginowan-shi, Okinawa, Japan
    • Osaka
      • Toyonaka-shi, Osaka, Japan
    • Saitama
      • Hasuda-shi, Saitama, Japan
      • Saitama-shi, Saitama, Japan
    • Shizuoka
      • Hamamatsu-shi, Shizuoka, Japan
      • Shizuoka-shi, Shizuoka, Japan
    • Tochigi
      • Shimotsuke-shi, Tochigi, Japan
    • Tokushima
      • Tokushima-shi, Tokushima, Japan
      • Yoshinogawa-shi, Tokushima, Japan
    • Tokyo
      • Bunkyo-ku, Tokyo, Japan
      • Kodaira-shi, Tokyo, Japan
      • Ota-ku, Tokyo, Japan
    • Wakayama
      • Wakayama-shi, Wakayama, Japan
    • Yamagata
      • Yonezawa-shi, Yamagata, Japan
    • Yamaguchi
      • Shimonoseki-shi, Yamaguchi, Japan
      • Yanai-shi, Yamaguchi, Japan

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Patients who have completed Phase II/III study of E0302 (E0302-J081-761, hereafter referred to as Study 761) except for those patients who discontinued the treatment of Study 761. Completed patients are defined as those who completed the treatment period of Study 761, those on 24-hour use of non-invasive positive pressure ventilation (NIPPV), or those who eventually resulted in the use of NIPPV.
  2. Patients who are able to submit written informed consent. If patients are duly capable of study consent but are unable to sign (or affix a seal) by themselves due to aggravation of disease condition, written informed consent can be obtained from a legally authorized representative who can sign on behalf of the patients after confirming the patients' agreement to study participation.

Exclusion Criteria:

  1. Patients with cognitive impairment.
  2. Pregnant women or women who may have a possibility of becoming pregnant.
  3. Patients or their partners who are not willing to use reliable contraception.
  4. Patients with severe disease in the renal, cardiovascular, hematological, or hepatic system (severe disease will be judged referring to "Ministry of Health, Labor and Welfare (MHLW) Drug Safety Dept. Notification No. 80, Drug Safety Classification Criteria for Severity of Adverse Drug Reaction by Medicinal Products, Grade 3." However, an event due to the primary disease will be precluded).
  5. Patients with malignant tumor.
  6. Patients who participated in another clinical study after the completion of Study 761.
  7. Patients with present illness or history of drug allergy or severe allergic disease (anaphylactic shock).
  8. Patients who are judged to be ineligible for study entry by the investigator or subinvestigator.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Drug: E0302 (mecobalamin)
Intramuscular injection, mecobalamin twice a week.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of participants with Adverse Events as a Measure of safety
Time Frame: Every 3 months
Every 3 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Survival rate
Time Frame: Every 3 months
Every 3 months
Functional rating scale
Time Frame: Every 3 months
Every 3 months
Percent-predicted forced vital capacity (%FVC.)
Time Frame: Every 3 months
Every 3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Eisai Co., Ltd.

Investigators

  • Study Director: Kazunori Saeki, Neuroscience Clinical Development Section. JAC PCU. Eisai Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2008

Primary Completion (Actual)

March 31, 2017

Study Completion (Actual)

March 31, 2017

Study Registration Dates

First Submitted

March 6, 2007

First Submitted That Met QC Criteria

March 7, 2007

First Posted (Estimated)

March 8, 2007

Study Record Updates

Last Update Posted (Estimated)

June 19, 2023

Last Update Submitted That Met QC Criteria

June 16, 2023

Last Verified

August 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • E0302-J081-762

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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