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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00445172
First Posted: March 8, 2007
Last Update Posted: August 23, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Eisai Inc. ( Eisai Co., Ltd. )
  Purpose
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 Intervention Phase
Amyotrophic Lateral Sclerosis (ALS) Drug: E0302 (mecobalamin) Phase 2 Phase 3

Study Type: Interventional
Study Design: 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)

Resource links provided by NLM:


Further study details as provided by Eisai Inc. ( Eisai Co., Ltd. ):

Primary Outcome Measures:
  • Number of participants with Adverse Events as a Measure of safety [ Time Frame: Every 3 months ]

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

Enrollment: 135
Actual Study Start Date: February 2008
Study Completion Date: March 31, 2017
Primary Completion Date: March 31, 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: E0302 (mecobalamin)
Intramuscular injection, mecobalamin twice a week.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   20 Years and older   (Adult, Senior)
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00445172


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     History of Changes
Other Study ID Numbers: E0302-J081-762
First Submitted: March 6, 2007
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:
Amyotrophic Lateral Sclerosis
Sclerosis
Motor Neuron Disease
Pathologic Processes
Neurodegenerative Diseases
Nervous System Diseases
Neuromuscular Diseases
Spinal Cord Diseases
Central Nervous System Diseases
TDP-43 Proteinopathies
Proteostasis Deficiencies
Metabolic Diseases