Surveillance of Using Novel free Radical scavenger, edaravone to Investigate Survival Effect for ALS patients in Japan

Surveillance of Using Novel free Radical scavenger, edaravone to Investigate Survival Effect for ALS patients in Japan - SUNRISE Japan

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000023978

Enrollment

700

Registered

2016-09-15

Start date

2015-10-13

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

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: ALS patients who receive an edaravone product for the first time (in case of transferred patients, ALS patients who have started the surveillance in the previous institution)

Exclusion criteria

Exclusion criteria: ALS patients who meet contraindications to the use of edaravone

Design outcomes

Primary

Measure	Time frame
Onset date of death and introduction of permanent artificial ventilation* *: Introduction of permanent artificial ventilation accompanied with tracheotomy	—

Secondary

Measure	Time frame
1) Onset date of the following events: - introduction of tube feeding - gastrostomy - introduction of intermittent non-invasive ventilatory assistance (e.g. NIPPV) - tracheotomy - inability to have a speech - inability to swallow - no function of the upper extremities - inability to walk independently - inability to turn over independently 2) ALSFRS-R Score	—

Countries

Japan

Contacts

Public ContactKaoru Ishizaki

Tanabe Pharma Corporation Pharmacovigilance Department

tp-pms-shinchoku.JP@ml.tanabe-pharma.com03-6743-7733

Outcome results