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Amyotrophic Lateral Sclerosis (ALS)Phase 2/3NCT00444613

A Study in Patients With Amyotrophic Lateral Sclerosis (ALS)

A Phase 2/3 study testing E0302 (mecobalamin) in people with Amyotrophic Lateral Sclerosis (ALS), run by Eisai Co., Ltd. at 44 sites in Japan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 20 years and older
Conditions the study is for
Amyotrophic Lateral Sclerosis (ALS)
What is being tested?
E0302 (mecobalamin)
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
373 participants
Where
44 sitesJapan
Study dates
Apr 2007to Jul 2014
Phase
Phase 2/3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
  • Patients who are aged 20 years or older at the time of obtaining informed consent.
  • 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.
  • Patients who are at stage 1 or 2 of the severity criteria for ALS.
  • Patients within 3-year elapsed time period from disease onset at the start of observation period.
  • Patients who can visit study site for out-patient treatment.

Who cannot join

  • Patients who underwent tracheostomy.
  • Patients who experienced non-invasive positive pressure ventilation.
  • Patients whose percent-predicted forced vital capacity (%FVC) is >=60%.
  • Patients with multiple disturbances of conduction detected by nerve conduction test.
  • Patients with neurological symptom(s) due to vitamin B12 deficiency.
  • 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.
Show all 14Show fewer
  • Patients with cognitive impairment.
  • Pregnant women or women with a possibility of becoming pregnant.
  • Patients or their partners who are not willing to use reliable contraception.
  • 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).
  • Patients with malignant tumor.
  • Patients who participated in another clinical study within 12 weeks before starting the observation period.
  • Patients with present illness or history of drug allergy or severe allergic disease (anaphylactic shock).
  • Patients who are judged to be ineligible for study entry by the investigator or subinvestigator.

Trial locations and contacts

44 sites in 1 country.

44 sites in 1 country

Japan44 sites

  • Study site

    Akita, Akita

  • Study site

    Aomori, Aomori

  • Study site

    Bunkyo-ku, Tokyo

  • Study site

    Chiba, Chiba

  • Study site

    Fukuoka, Fukuoka

  • Study site

    Fukushima, Fukushima

  • Study site

    Ginowan-shi, Okinawa

  • Study site

    Hamamatsu, Shizuoka

  • Study site

    Hasuda-shi, Saitama

  • Study site

    Higashihiroshima-shi, Hiroshima

  • Study site

    Higashisonogi-gun, Nagasaki

  • Study site

    Ichinoseki-shi, Iwate

  • Study site

    Kanazawa, Ishikawa-ken

  • Study site

    Kashiwazaki-shi, Niigata

  • Study site

    Kitakyusyu-shi, Fukuoka

  • Study site

    Kodaira-shi, Tokyo

  • Study site

    Kyoto, Kyoto

  • Study site

    Maebashi, Gunma

  • Study site

    Miyoshi-shi, Hiroshima

  • Study site

    Nagano, Nagano

  • Study site

    Nagoya, Aichi-ken

  • Study site

    Nangoku-shi, Kochi

  • Study site

    Niigata, Niigata

  • Study site

    Ōta-ku, Tokyo

  • Study site

    Otake-shi, Hiroshima

  • Study site

    Ōtsu, Shiga

  • Study site

    Sagamihara-shi, Kanagawa

  • Study site

    Saitama-shi, Saitama

  • Study site

    Sapporo, Hokkaido

  • Study site

    Sendai, Miyagi

  • Study site

    Shimonoseki-shi, Yamaguchi

  • Study site

    Shimotsuke-shi, Tochigi

  • Study site

    Shizuoka, Shizuoka

  • Study site

    Tokushima, Tokushima

  • Study site

    Touon-shi, Ehime

  • Study site

    Toyonaka-shi, Osaka

  • Study site

    Tsu, Mie-ken

  • Study site

    Tsukubo-gun, Okayama-ken

  • Study site

    Wakayama, Wakayama

  • Study site

    Watari-gun, Miyagi

  • Study site

    Yanai-shi, Yamaguchi

  • Study site

    Yokohama, Kanagawa

  • Study site

    Yonezawa-shi, Yamagata

  • Study site

    Yoshinogawa-shi, Tokushima

Other trials in Japan

About this study

Official title: 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.

Being tested
E0302 (mecobalamin), Placebo
Keywords
Amyotrophic Lateral Sclerosis (ALS), motor neurons, muscular atrophy, Lou Gehrig's Disease
Medical subject headings
Amyotrophic Lateral Sclerosis, Muscular Atrophy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • E0302 (mecobalamin)Drug

    Also called mecobalamin

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

  • E0302 (mecobalamin)Drug

    Also called mecobalamin

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

  • PlaceboDrug

    Intramuscular injection, placebo twice a week for 3.5 years.

Study groups in NCT00444613
Study groupRoleWhat they receive
E0302 25 mgExperimentalNot described
Receives: Drug: E0302 (mecobalamin)
E0302 50 mgExperimentalNot described
Receives: Drug: E0302 (mecobalamin)
3Placebo comparatorNot described
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Survival rate

    Measured: Every 3 months.

  2. Functional rating scale.

    Measured: Every 3 months.

Secondary outcomes (2)

  1. Manual Muscle Test (MMT)

    Measured: Every 3 months.

  2. Percent-predicted forced vital capacity (%FVC)

    Measured: Every 3 months.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Mar 2007 (estimated)
  2. Study startApr 2007
  3. Primary completionMar 2014
  4. Study completionJul 2014

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2/3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
373 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00444613
Sponsor's protocol ID
E0302-J081-761
Status last verified
Dec 2014
First submitted
6 Mar 2007
Last updated
18 Jun 2023
Results posted
No

Publications

  • Kaji R, Imai T, Iwasaki Y, Okamoto K, Nakagawa M, Ohashi Y, Takase T, Hanada T, Shimizu H, Tashiro K, Kuzuhara S. Ultra-high-dose methylcobalamin in amyotrophic lateral sclerosis: a long-term phase II/III randomised controlled study. J Neurol Neurosurg Psychiatry. 2019 Apr;90(4):451-457. doi: 10.1136/jnnp-2018-319294. Epub 2019 Jan 13.

    PubMed 30636701

  • Ikeda K, Iwasaki Y, Kaji R. Neuroprotective effect of ultra-high dose methylcobalamin in wobbler mouse model of amyotrophic lateral sclerosis. J Neurol Sci. 2015 Jul 15;354(1-2):70-4. doi: 10.1016/j.jns.2015.04.052. Epub 2015 May 8.

    PubMed 25982504

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing E0302 (mecobalamin) in people with Amyotrophic Lateral Sclerosis (ALS), run by Eisai Co., Ltd. at 44 sites in Japan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 44 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Survival rate (time frame: Every 3 months.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00444613, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2023.

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