A Long-Term Study in Patients With Amyotrophic Lateral Sclerosis (ALS)

• ClinicalTrials.gov Identifier: NCT00445172
• Recruitment Status: Completed
• First Posted: March 8, 2007
• Last Update Posted: August 23, 2017
• Sponsor: Eisai Co., Ltd.
• Information provided by (Responsible Party): Eisai Inc. ( Eisai Co., Ltd. )

Study Description

Brief Summary:

The purpose of this study is to investigate the safety and efficacy of long-term E0302 administration in patients with Amyotrophic Lateral Sclerosis (ALS).

Condition or disease	Intervention/treatment	Phase
Amyotrophic Lateral Sclerosis (ALS)	Drug: E0302 (mecobalamin)	Phase 2; Phase 3

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 135 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Long-Term Study in Patients With Amyotrophic Lateral Sclerosis (ALS)
• Actual Study Start Date: February 2008
• Actual Primary Completion Date: March 31, 2017
• Actual Study Completion Date: March 31, 2017

Arms and Interventions

Arm	Intervention/treatment
Experimental: 1	Drug: E0302 (mecobalamin); Intramuscular injection, mecobalamin twice a week.

Outcome Measures

Primary Outcome Measures :

1. Number of participants with Adverse Events as a Measure of safety [ Time Frame: Every 3 months ]

Secondary Outcome Measures :

1. Survival rate [ Time Frame: Every 3 months ]
2. Functional rating scale [ Time Frame: Every 3 months ]
3. Percent-predicted forced vital capacity (%FVC.) [ Time Frame: Every 3 months ]

Eligibility Criteria

• Ages Eligible for Study: 20 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

1. Patients who have completed Phase II/III study of E0302 (E0302-J081-761, hereafter referred to as Study 761) except for those patients who discontinued the treatment of Study 761. Completed patients are defined as those who completed the treatment period of Study 761, those on 24-hour use of non-invasive positive pressure ventilation (NIPPV), or those who eventually resulted in the use of NIPPV.
2. 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.

Exclusion Criteria:

1. Patients with cognitive impairment.
2. Pregnant women or women who may have a possibility of becoming pregnant.
3. Patients or their partners who are not willing to use reliable contraception.
4. 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." However, an event due to the primary disease will be precluded).
5. Patients with malignant tumor.
6. Patients who participated in another clinical study after the completion of Study 761.
7. Patients with present illness or history of drug allergy or severe allergic disease (anaphylactic shock).
8. Patients who are judged to be ineligible for study entry by the investigator or subinvestigator.

Contacts and Locations

Locations

Japan

Nagoya-shi, Aichi, Japan

Aomori-shi, Aomori, Japan

Chiba-shi, Chiba, Japan

Touon-shi, Ehime, Japan

Fukuoka-shi, Fukuoka, Japan

Kitakyushi-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

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

• Responsible Party: Eisai Co., Ltd.
• ClinicalTrials.gov Identifier: NCT00445172
• Other Study ID Numbers: E0302-J081-762
• First Posted: March 8, 2007
• Last Update Posted: August 23, 2017
• Last Verified: August 2017

Keywords provided by Eisai Inc. ( Eisai Co., Ltd. ):

Amyotrophic Lateral Sclerosis; Motor Neurons; Muscular Atrophy

Additional relevant MeSH terms:

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