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WALKALS : A pilot phase II study to evaluate the effect of salbutamol on walking capacity in ambulatory ALS patients.

Status
Not yet recruiting
Phases
Phase 2
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2022-501624-14-00
Acronym
APHP190724
Enrollment
36
Registered
2023-05-05
Start date
Unknown
Completion date
Unknown
Last updated
2023-08-18

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

Conditions

Amyotrophic Lateral Sclerosis (ALS)

Brief summary

Two primary endpoints will be used: change from baseline of the 6 minutes walking test distance (6MWT) at M3 (2mg TID) and at M6 (4mg TID) with type I error controlled through Bonferroni correction.

Interventions

DRUGVentoline 0
DRUG4 mg/ml oral lösning
DRUGPlacebo of salbutamol

Sponsors

Assistance Publique Hopitaux De Paris, Assistance Publique Hopitaux De Paris
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Two primary endpoints will be used: change from baseline of the 6 minutes walking test distance (6MWT) at M3 (2mg TID) and at M6 (4mg TID) with type I error controlled through Bonferroni correction.—

Countries

France

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026