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

Status: Recruiting
Location: See all (3) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Ability to provide written informed consent.

• Adults \>18 years of age with a diagnosis of symptomatic ALS as determined by an ALS neurologist, and meets either the revised El Escorial Criteria (clinically possible, probable, probable lab-supported, or definite) or the Gold Coast Criteria.

• Available or pending CLIA certified ALS genetic panel report.

• Less than or equal to 24-months since onset of weakness attributed to ALS.

• Vital capacity (VC) of \> 65% predicted value for gender, height and age at screening.

• Clinically unremarkable Complete Blood Counts, including but not limited to Hemoglobin ≥ 9 g/dL, Platelets ≥ 150 x 109 cells/L.

• No clinically significant abnormalities in the Comprehensive Metabolic Panel per site/sub-investigator's judgment, including but not limited to:

∙ Serum alanine aminotransferase or aspartate aminotransferase \< 3× upper limit of normal, or serum total bilirubin \<1.5× upper limit of normal

‣ Estimated GFR (eGFR) of \> 30 mL/min/1.73m2

‣ Other clinically significant electrolyte and metabolic abnormalities

• Ability and willingness to complete all study procedures per the Site Investigator's clinical assessment.

• Negative pregnancy test within 7 days prior to first dose for women of child-bearing potential (WOCB), defined as a sexually mature woman who has not undergone a hysterectomy or who has not been naturally postmenopausal for at least 24 consecutive months (i.e., who has had menses any time in the preceding 24 consecutive months).

⁃ Individuals enrolling in the C9orf72 cohort of the trial must have CLIA certified ALS gene panel demonstrating \>31 repeats of C9orf72 hexanucleotide repeat expansion, deemed pathologic.

Locations
United States
Florida
Nova Southeastern University
RECRUITING
Davie
Illinois
Northwestern Universsity
RECRUITING
Chicago
Massachusetts
MGH
RECRUITING
Boston
Contact Information
Primary
Ashlyn Butkowski
abutkowski@mgb.org
857-282-9210
Time Frame
Start Date: 2025-05-27
Estimated Completion Date: 2026-04
Participants
Target number of participants: 40
Treatments
Experimental: Treatment Group
Sponsors
Leads: Massachusetts General Hospital

This content was sourced from clinicaltrials.gov