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

JRCT ID: jRCT2031240291

Registered date:22/08/2024

Basic Information

• Recruitment status: Pending
• Health condition(s) or Problem(s) studied: Amyotrophic Lateral Sclerosis
• Date of first enrollment: 22/08/2024
• Target sample size: 10
• Study type: Interventional
• Intervention(s): Administer E0302 50 mg intramuscularly twice a week.

Outcome(s)

• Primary 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
• Secondary Outcome: NONE

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Include criteria: The primary objective of Tsunagi phase is to provide E0302 to those patients who are enrolled in E0302-TOK-763 OLE Phase, until the drug becomes commercially available (compassionate use). The secondary objective is to assess the efficacy and safety of E0302 in patients who are enrolled in E0302-TOK-763 Tsunagi Phase.
• Exclude criteria: none

Related Information

• Primary Sponsor: Endo Akira
• Secondary ID(s): NCT03548311