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

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	Phase II Phase III

Genetics Home Reference related topics:

amyotrophic lateral sclerosis

MedlinePlus related topics:

Amyotrophic Lateral Sclerosis

Drug Information available for:

Mecobalamin

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study

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

Further study details as provided by Eisai Medical Research Inc.:

Primary Outcome Measures:

Safety [ Time Frame: 12 Weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	300
Study Start Date:	March 2007
Estimated Primary Completion Date:	January 2014 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	Drug: E0302 Drug: E0302 Muscle Injection, twice a week.

Eligibility

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

Criteria

Inclusion Criteria:

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.
Patients who are able to submit written informed consent. If patients are unable to sign (or affix a seal) by themselves due to aggravation of disease condition even though patients are duly capable of study consent, 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:

Patients with cognitive impairment
Pregnant women or women who may have 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." However, an event due to the primary disease will be precluded).
Patients with malignant tumor.
Patients who participated in another clinical study after the completion of Study 761.
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: NCT00445172

Contacts


Contact: Customer Information Service Department. CRC and QA	ML_CLNCL@hhc.eisai.co.jp

Locations


Japan, Miyagi
		Recruiting
	Watari-gun, Miyagi, Japan

Japan, Okayama
		Recruiting
	Tsukubo-gun, Okayama, Japan

Japan, Saitama
		Recruiting
	Saitama-shi, Saitama, Japan

Sponsors and Collaborators

Eisai Limited

Investigators


Study Director:	Kazunori Saeki	Department New Drug Development Clinical Research Center

More Information

Responsible Party:	Eisai Company Ltd. ( Department of New Product Development, Clinical Research Center )
Study ID Numbers:	E0302-J081-762
First Received:	March 6, 2007
Last Updated:	September 5, 2008
ClinicalTrials.gov Identifier:	NCT00445172
Health Authority:	Japan: Ministry of Health, Labor and Welfare