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

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2031240291

Enrollment

Registered

2024-08-22

Start date

2024-08-22

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Amyotrophic Lateral Sclerosis

Interventions

Administer E0302 50 mg intramuscularly twice a week.

Eligibility

Inclusion criteria

Inclusion 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.

Exclusion criteria

Exclusion criteria: none

Design outcomes

Primary

Measure	Time frame
NONE	—

Secondary

Measure	Time frame
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	—

Contacts

Public ContactService Inquiry

Eisai Co. Ltd.

eisai-chiken_hotline@hhc.eisai.co.jp+81-120-419-497

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026