A Study in Patients With Amyotrophic Lateral Sclerosis (ALS)

June 16, 2023 updated by: Eisai Co., Ltd.

A Phase II/III Study in Patients With Amyotrophic Lateral Sclerosis (ALS)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

373

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
    • Akita
      • Akita-shi, Akita, Japan
    • Aomori
      • Aomori-shi, Aomori, Japan
    • Chiba
      • Chiba-shi, Chiba, Japan
    • Ehime
      • Touon-shi, Ehime, Japan
    • Fukuoka
      • Fukuoka-shi, Fukuoka, Japan
      • Kitakyusyu-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
    • Shiga
      • Otsu-shi, Shiga, 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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. 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.
  2. Patients who are aged 20 years or older at the time of obtaining informed consent.
  3. Patients who have clinically definite ALS, clinically probable ALS, or clinically probable-laboratory supported ALS as specified in the revised El Escorial Airlie House diagnostic criteria.
  4. Patients who are at stage 1 or 2 of the severity criteria for ALS.
  5. Patients within 3-year elapsed time period from disease onset at the start of observation period.
  6. Patients who can visit study site for out-patient treatment.

Exclusion Criteria:

  1. Patients who underwent tracheostomy.
  2. Patients who experienced non-invasive positive pressure ventilation.
  3. Patients whose percent-predicted forced vital capacity (%FVC) is >=60%.
  4. Patients with multiple disturbances of conduction detected by nerve conduction test.
  5. Patients with neurological symptom(s) due to vitamin B12 deficiency.
  6. Patients who initiated newly introduced riluzole therapy after starting the observation period. Or those who received dose escalation or resumed administration of riluzole therapy after previous down titration or discontinuation.
  7. Patients with cognitive impairment.
  8. Pregnant women or women with a possibility of becoming pregnant.
  9. Patients or their partners who are not willing to use reliable contraception.
  10. 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).
  11. Patients with malignant tumor.
  12. Patients who participated in another clinical study within 12 weeks before starting the observation period.
  13. Patients with present illness or history of drug allergy or severe allergic disease (anaphylactic shock).
  14. 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: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: 3
Drug: Placebo
Intramuscular injection, placebo twice a week for 3.5 years.
Experimental: E0302 25 mg
Drug: E0302 (mecobalamin)
Intramuscular injection, mecobalamin 25 mg twice a week for 3.5 years.
Other Names:
  • mecobalamin
Drug: E0302 (mecobalamin)
Intramuscular injection, mecobalamin 50 mg twice a week for 3.5 years.
Other Names:
  • mecobalamin
Experimental: E0302 50 mg
Drug: E0302 (mecobalamin)
Intramuscular injection, mecobalamin 25 mg twice a week for 3.5 years.
Other Names:
  • mecobalamin
Drug: E0302 (mecobalamin)
Intramuscular injection, mecobalamin 50 mg twice a week for 3.5 years.
Other Names:
  • mecobalamin

What is the study measuring?

Primary 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.

Secondary Outcome Measures

Outcome Measure
Time Frame
Manual Muscle Test (MMT)
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.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

April 1, 2007

Primary Completion (Actual)

March 1, 2014

Study Completion (Actual)

July 1, 2014

Study Registration Dates

First Submitted

March 6, 2007

First Submitted That Met QC Criteria

March 6, 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

December 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • E0302-J081-761

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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