Overview

This trial is active, not recruiting.

Condition amyotrophic lateral sclerosis (als)
Treatment e0302 (mecobalamin)
Phase phase 2/phase 3
Sponsor Eisai Co., Ltd.
Start date February 2008
End date March 2017
Trial size 300 participants
Trial identifier NCT00445172, E0302-J081-762

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).

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
e0302 (mecobalamin)
Intramuscular injection, mecobalamin twice a week.

Primary Outcomes

Measure
Number of participants with Adverse Events as a Measure of safety
time frame: Every 3 months

Secondary Outcomes

Measure
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

Eligibility Criteria

Male or female participants at least 20 years old.

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.

Additional Information

Official title A Long-Term Study in Patients With Amyotrophic Lateral Sclerosis (ALS)
Trial information was received from ClinicalTrials.gov and was last updated in February 2016.
Information provided to ClinicalTrials.gov by Eisai Inc..