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 |
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Health condition(s) or Problem(s) studied | Amyotrophic Lateral Sclerosis |
Date of first enrollment | 22/08/2024 |
Target sample size | 10 |
Countries of recruitment | |
Study type | Interventional |
Intervention(s) | Administer E0302 50 mg intramuscularly twice a week. |
Outcome(s)
Primary Outcome | NONE |
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Secondary Outcome | Time 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 |
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Age maximum | Not applicable |
Gender | |
Include criteria | The 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 criteria | none |
Related Information
Primary Sponsor | Endo Akira |
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Secondary Sponsor | |
Source(s) of Monetary Support | |
Secondary ID(s) | NCT03548311 |
Contact
Public contact | |
Name | Service Inquiry |
Address | 6-10 KOISHIKAWA 4-CHOME BUNKYO-KU TOKYO Tokyo Japan 112-8088 |
Telephone | +81-120-419-497 |
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 |
eisai-chiken_hotline@hhc.eisai.co.jp | |
Affiliation | Eisai Co. Ltd. |