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

Study 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).

Disease:

Amyotrophic Lateral Sclerosis (ALS),  Familial ALS,  Sporadic ALS

Study Type:

Interventional Trial

Study Category:

Drug Trial

Study Status:

Closed

Phase:

Phase III

Study Chair(s)/Principal Investigator(s):

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

Clinicaltrials.gov ID (11 digit #):

NCT00445172

Neals Affiliated?

No

Coordinating Center Contact Information


.(JavaScript must be enabled to view this email address)
.(JavaScript must be enabled to view this email address) United States

Full Study Summary:

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

Secondary 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 ]
-Percent-predicted forced vital capacity (%FVC.) [ Time Frame: Every 3 months ] [ Designated as safety issue: No ]

Study Sponsor:

Eisai Co., Ltd.

Participant Duration:

Estimated Enrollment:

300

Estimated Study Start Date:

01/31/2008

Estimated Study Completion Date:

10/31/2016

Posting Last Modified Date:

11/02/2016

Date Study Added to alsconsortium.org:

08/18/2015
  • More Information
  • Eligibility Criteria

    Gender:

    Female, Male

    Minimum Age:

    20

    Maximum Age:

    N/A

    Time since Symptom Onset:

    Time since Diagnosis:

    Can participants use Riluzole?


    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 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:
    -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.

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