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

Study Purpose:

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 Status:

Not recruiting

Disease:

Amyotrophic Lateral Sclerosis (ALS)

Study Type:

Interventional

Type of Intervention:

Drug

Intervention Name:

E0302 (mecobalamin), Placebo

Placebo:

Phase:

Phase 2/Phase 3

Study Chair(s)/Principal Investigator(s):

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

Clinicaltrials.gov ID:

NCT00444613

Neals Affiliated?

No

Coordinating Center Contact Information

Japan

Full Study Summary:

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

Study Sponsor:

Eisai Co., Ltd.

Estimated Enrollment:

373

Estimated Study Start Date:

03 / 31 / 2007

Estimated Study Completion Date:

07 / 01 / 2014

Posting Last Modified Date:

12 / 08 / 2014

Date Study Added to neals.org:

03 / 08 / 2007

Alternative Study Name: A Study in Patients With Amyotrophic Lateral Sclerosis (ALS)

Minimum Age:

20 Years

Maximum Age:

N/A

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.

Nagoya-shi, Aichi
Japan

Shizuoka-shi, Shizuoka
Japan

Niigata-shi, Niigata
Japan

Tsukubo-gun, Okayama
Japan

Ginowan-shi, Okinawa
Japan

Toyonaka-shi, Osaka
Japan

Hasuda-shi, Saitama
Japan

Saitama-shi, Saitama
Japan

Otsu-shi, Shiga
Japan

Hamamatsu-shi, Shizuoka
Japan

Shimotsuke-shi, Tochigi
Japan

Higashisonogi-gun, Nagasaki
Japan

Tokushima-shi, Tokushima
Japan

Yoshinogawa-shi, Tokushima
Japan

Bunkyo-ku, Tokyo
Japan

Kodaira-shi, Tokyo
Japan

Ota-ku, Tokyo
Japan

Wakayama-shi, Wakayama
Japan

Yonezawa-shi, Yamagata
Japan

Shimonoseki-shi, Yamaguchi
Japan

Kashiwazaki-shi, Niigata
Japan

Nagano-shi, Nagano
Japan

Akita-shi, Akita
Japan

Miyoshi-shi, Hiroshima
Japan

Aomori-shi, Aomori
Japan

Chiba-shi, Chiba
Japan

Touon-shi, Ehime
Japan

Fukuoka-shi, Fukuoka
Japan

Kitakyusyu-shi, Fukuoka
Japan

Fukushima-shi, Fukushima
Japan

Maebashi-shi, Gunma
Japan

Higashihiroshima-shi, Hiroshima
Japan

Otake-shi, Hiroshima
Japan

Watari-gun, Miyagi
Japan

Sapporo-shi, Hokkaido
Japan

Kanazawa-shi, Ishikawa
Japan

Ichinoseki-shi, Iwate
Japan

Sagamihara-shi, Kanagawa
Japan

Yokohama-shi, Kanagawa
Japan

Nangoku-shi, Kochi
Japan

Kyoto-shi, Kyoto
Japan

Tsu-shi, Mie
Japan

Sendai-shi, Miyagi
Japan

Yanai-shi, Yamaguchi
Japan