A Study in Patients With Amyotrophic Lateral Sclerosis (ALS)

NCT ID: NCT00444613

Last Updated: 2023-06-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 373 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-04-30
• Study Completion Date: 2014-07-31

Brief 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)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

E0302 25 mg

Group Type: EXPERIMENTAL

E0302 (mecobalamin)

Intervention Type: DRUG

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

E0302 50 mg

Group Type: EXPERIMENTAL

E0302 (mecobalamin)

Intervention Type: DRUG

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

3

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Intramuscular injection, placebo twice a week for 3.5 years.

Interventions

E0302 (mecobalamin)

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

Intervention Type: DRUG

E0302 (mecobalamin)

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

Intervention Type: DRUG

Placebo

Intramuscular injection, placebo twice a week for 3.5 years.

Intervention Type: DRUG

Other Intervention Names

mecobalamin; mecobalamin

Eligibility Criteria

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.

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Eisai Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kazunori Saeki

Role: STUDY_DIRECTOR

Neuroscience Clinical Development Section. JAC PCU. Eisai Co., Ltd.

Locations

Nagoya, Aichi-ken, Japan

Akita, Akita, Japan

Aomori, Aomori, Japan

Chiba, Chiba, Japan

Touon-shi, Ehime, Japan

Fukuoka, Fukuoka, Japan

Kitakyusyu-shi, Fukuoka, Japan

Fukushima, Fukushima, Japan

Maebashi, Gunma, Japan

Higashihiroshima-shi, Hiroshima, Japan

Miyoshi-shi, Hiroshima, Japan

Otake-shi, Hiroshima, Japan

Sapporo, Hokkaido, Japan

Kanazawa, Ishikawa-ken, Japan

Ichinoseki-shi, Iwate, Japan

Sagamihara-shi, Kanagawa, Japan

Yokohama, Kanagawa, Japan

Nangoku-shi, Kochi, Japan

Kyoto, Kyoto, Japan

Tsu, Mie-ken, Japan

Sendai, Miyagi, Japan

Watari-gun, Miyagi, Japan

Nagano, Nagano, Japan

Higashisonogi-gun, Nagasaki, Japan

Kashiwazaki-shi, Niigata, Japan

Niigata, Niigata, Japan

Tsukubo-gun, Okayama-ken, Japan

Ginowan-shi, Okinawa, Japan

Toyonaka-shi, Osaka, Japan

Hasuda-shi, Saitama, Japan

Saitama-shi, Saitama, Japan

Ōtsu, Shiga, Japan

Hamamatsu, Shizuoka, Japan

Shizuoka, Shizuoka, Japan

Shimotsuke-shi, Tochigi, Japan

Tokushima, Tokushima, Japan

Yoshinogawa-shi, Tokushima, Japan

Bunkyo-ku, Tokyo, Japan

Kodaira-shi, Tokyo, Japan

Ōta-ku, Tokyo, Japan

Wakayama, Wakayama, Japan

Yonezawa-shi, Yamagata, Japan

Shimonoseki-shi, Yamaguchi, Japan

Yanai-shi, Yamaguchi, Japan

Countries

Japan

References

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.

Reference Type: DERIVED

PMID: 30636701 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 25982504 (View on PubMed)

Other Identifiers

E0302-J081-761

Identifier Type: -

Identifier Source: org_study_id