NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
JRCT ID: jRCT2031240291

Registered date:22/08/2024

A Phase 3 Study of High dose E0302 against Amyotrophic Lateral Sclerosis - Investigator Initiated Study ("Tsunagi" phase)

Basic Information

Recruitment status Not Recruiting
Health condition(s) or Problem(s) studiedAmyotrophic Lateral Sclerosis
Date of first enrollment22/08/2024
Target sample size10
Countries of recruitment
Study typeInterventional
Intervention(s)Administer E0302 50 mg intramuscularly twice a week.

Outcome(s)

Primary OutcomeNONE
Secondary OutcomeTime period from drug assignment to death or becoming bound to respirator, changes of sum of ALSFRS-R, laboratory tests, vital signs, and adverse events

Key inclusion & exclusion criteria

Age minimum>= 20age old
Age maximumNot applicable
Gender
Include criteriaThe subjects for the Tsunagi phase are patients with ALS who are continuing the administration of this drug at the time of approval, and have obtained consent for the transition to the Tsunagi phase.
Exclude criterianone

Related Information

Contact

Public contact
Name Service Inquiry
Address 6-10 KOISHIKAWA 4-CHOME BUNKYO-KU TOKYO Tokyo Japan 112-8088
Telephone +81-120-419-497
E-mail eisai-chiken_hotline@hhc.eisai.co.jp
Affiliation Eisai Co. Ltd.
Scientific contact
Name Akira Endo
Address 6-10 KOISHIKAWA 4-CHOME BUNKYO-KU TOKYO Tokyo Japan 112-8088
Telephone +81-120-419-497
E-mail eisai-chiken_hotline@hhc.eisai.co.jp
Affiliation Eisai Co. Ltd.