NCT07047209

Trial of Oral Digoxin in Individuals With Amyotrophic Lateral Sclerosis (ALS)

A Phase 2a Biomarker-Driven Trial of Oral Digoxin in Individuals With Amyotrophic Lateral Sclerosis (ALS) - The Acacia Trial, an ALS MyMatch Trial

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Massachusetts General Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This clinical trial is being conducted to learn about safety and tolerability of digoxin in ALS individuals. Additionally, this trial aims to better understand if digoxin has an effect on slowing neurodegeneration in ALS.

Detailed description

This is a single-arm, Phase 2a, open label, 24-week treatment trial evaluating standard clinical dosages of commercially available, FDA approved oral digoxin in up to 40 eligible ALS participants with early disease (\<24 months from symptom onset). The trial will include two cohorts of eligible participants; Cohort 1 of approximately 30 sporadic/non-C9 ALS and Cohort 2 of approximately 10 C9orf72(+) ALS individuals.

Conditions

• ALS (Amyotrophic Lateral Sclerosis)

Interventions

Type	Name	Description
DRUG	Digoxin	Digoxin tablets will be administered orally in a once daily dosage. Each tablet is scored and is of 125 mcg strength. Participants will take 1 tablet, two tablets or half a tablet depending on the dosing tier they are in during study participation.

Timeline

• Start date: 2025-05-27
• Primary completion: 2026-03-01
• Completion: 2026-04-01
• First posted: 2025-07-02
• Last updated: 2025-10-30

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated drug study