A multi-center, prospective, non-interventional registry study of Edaravone Sublingual Tablets for Amyotrophic Lateral Sclerosis (ALS) (Real World Study)

Status

Recruiting

Phases

Phase 4

Study type

Observational

Source

ChiCTR

Registry ID

ChiCTR2400091187

Enrollment

Unknown

Registered

2024-10-22

Start date

2023-10-15

Completion date

Unknown

Last updated

2024-10-28

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

Conditions

Amyotrophic lateral sclerosis

Interventions

Case series:NA

Eligibility

Sex/Gender

All

Age

14 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. The patients meet the amyotrophic lateral sclerosis /2020 diagnostic criteria (Gold Coast Criteria) ; 2. ALS patients who have been prescribed sublingual tablets of edaravone by doctors; 3. The patients voluntarily participate in this study, and the patients themselves or their guardians sign informed consent forms.

Exclusion criteria

Exclusion criteria: Pregnant women, lactating women

Design outcomes

Primary

Measure	Time frame
Change in ALSFRS-R score;	—

Secondary

Measure	Time frame
Time to ALSFRS-R score drop =12 points or death;Change in ALSAQ-40 score;Change in ROADS score;Time to tracheostomy or permanent assisted mechanical ventilation;	—

Countries

China

Contacts

Public ContactDongsheng Fan

Peking University Third Hospital

dsfan@sina.com+86 137 0102 3871

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026