A Study in Patients With Amyotrophic Lateral Sclerosis (ALS) - Full Text View

Sponsor:	Eisai Co., Ltd.
Information provided by (Responsible Party):	Eisai Inc. ( Eisai Co., Ltd. )
ClinicalTrials.gov Identifier:	NCT00444613

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.

Condition	Intervention	Phase
Amyotrophic Lateral Sclerosis (ALS)	Drug: E0302 (mecobalamin) Drug: Placebo	Phase II Phase III

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment
Official Title:	A Phase II/III Study in Patients With Amyotrophic Lateral Sclerosis (ALS)

Resource links provided by NLM:

Genetics Home Reference related topics: amyotrophic lateral sclerosis

MedlinePlus related topics: Amyotrophic Lateral Sclerosis

Drug Information available for: Mecobalamin

U.S. FDA Resources

Further study details as provided by Eisai Inc.:

Primary Outcome Measures:

Survival rate [ Time Frame: Every 3 months. ] [ Designated as safety issue: No ]
Functional rating scale. [ Time Frame: Every 3 months. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Manual Muscle Test (MMT) [ Time Frame: Every 3 months ] [ Designated as safety issue: No ]
Percent-predicted forced vital capacity (%FVC) [ Time Frame: Every 3 months ] [ Designated as safety issue: No ]

Estimated Enrollment:	360
Study Start Date:	April 2007
Estimated Study Completion Date:	March 2014
Estimated Primary Completion Date:	March 2014 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: E0302 25 mg	Drug: E0302 (mecobalamin) Intramuscular injection, mecobalamin 25 mg twice a week for 3.5 years. Other Name: mecobalamin
Experimental: E0302 50 mg	Drug: E0302 (mecobalamin) Intramuscular injection, mecobalamin 50 mg twice a week for 3.5 years. Other Name: mecobalamin
Placebo Comparator: 3	Drug: Placebo Intramuscular injection, placebo twice a week for 3.5 years.

Eligibility

Ages Eligible for Study:	20 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

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.
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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00444613

Locations

Japan

Nagoya-shi, Aichi, Japan

Akita-shi, Akita, 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

Miyoshi-shi, Hiroshima, Japan

Otake-shi, Hiroshima, 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

Watari-gun, Miyagi, Japan

Nagano-shi, Nagano, Japan

Higashisonogi-gun, Nagasaki, Japan

Kashiwazaki-shi, Niigata, 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

Shizuoka-shi, Shizuoka, Japan

Shimotsuke-shi, Tochigi, 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

Yanai-shi, Yamaguchi, Japan

Sponsors and Collaborators

Eisai Co., Ltd.

Investigators

Study Director:

Kazunori Saeki

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

More Information

No publications provided

Responsible Party:	Eisai Inc. ( Eisai Co., Ltd. )
ClinicalTrials.gov Identifier:	NCT00444613 History of Changes
Other Study ID Numbers:	E0302-J081-761
Study First Received:	March 6, 2007
Last Updated:	October 10, 2011
Health Authority:	Japan: Ministry of Health, Labor and Welfare

Keywords provided by Eisai Inc.:

Amyotrophic Lateral Sclerosis (ALS)
motor neurons
muscular atrophy
Lou Gehrig's Disease

Additional relevant MeSH terms:

Amyotrophic Lateral Sclerosis
Sclerosis
Motor Neuron Disease
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurodegenerative Diseases
TDP-43 Proteinopathies
Neuromuscular Diseases
Proteostasis Deficiencies

Metabolic Diseases
Pathologic Processes
Vitamin B 12
Vitamin B Complex
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 09, 2012