Observational study on clinical course and prognostic factors of amyotrophic lateral sclerosis (ALS)

Observational study on clinical course and prognostic factors of amyotrophic lateral sclerosis (ALS) - Observational study for amyotrophic lateral sclerosis (ALS)

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000041729

Enrollment

600

Registered

2020-11-01

Start date

2020-10-28

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: Patients who were diagnosed as "possible ALS", "probable ALs laboratory-supported", "probable ALS", or "definite ALS" in the El Escorial diagnostic criteria revised. Otherwise, patients who were diagnosed as "possible ALS", "probable ALs laboratory-supported", "probable ALS", or "definite ALS" in the updated Awaji criteria. Both sporadic and familial ALS patients will be assigned.

Exclusion criteria

Exclusion criteria: 1. Patients who have participated in a clinical trial for ALS and have been administered the investigational drug 2. Patients who have other serious complications and are considered unsuitable for the natural history survey by the investigator

Design outcomes

Primary

Measure	Time frame
1. ALSFRS-R change rate 2. Period from onset to death or tracheostomy/invasive positive pressure ventilation 3. Period from onset to full-day non-invasive positive pressure ventilation (>22 hours/day)	—

Countries

Japan

Contacts

Public ContactTomomi Shijo

Tohoku University Hospital Department of Neurology

shijo-t@med.tohoku.ac.jp022-717-7189

Outcome results