A Phase III, Randomized, Double-Blind, Placebo-Controlled, Multicenter Trial to Evaluate the Safety and Efficacy of AMX0035 Versus Placebo for 48-week Treatment of Adult Patients with Amyotrophic Lateral Sclerosis (ALS)

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2023-508511-23-00

Acronym

A35-004

Enrollment

526

Registered

2024-07-09

Start date

2021-12-02

Completion date

2025-01-13

Last updated

2024-08-04

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

Change from baseline in ALSFRS-R total score at Week 48 adjusting for mortality

Detailed description

Change from baseline in ALSAQ-40 Total Score at Week 48, Overall survival, Change from baseline to Week 48 of the percent predicted SVC using in clinic visits, Change from baseline in ALSFRS-R total score at Week 24

Interventions

DRUGAMX0035

DRUGPL1 Oral powder in sachet

DRUGoral use

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Change from baseline in ALSFRS-R total score at Week 48 adjusting for mortality	—

Secondary

Measure	Time frame
Change from baseline in ALSAQ-40 Total Score at Week 48, Overall survival, Change from baseline to Week 48 of the percent predicted SVC using in clinic visits, Change from baseline in ALSFRS-R total score at Week 24	—

Countries

Belgium, France, Germany, Ireland, Italy, Netherlands, Poland, Portugal, Spain, Sweden

Outcome results

None listed

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