ACTIVE_NOT_RECRUITING

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

Conditions

ALS (Amyotrophic Lateral Sclerosis)ALS Amyotrophic Lateral Sclerosis Early ALS

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2025-05-27

Study Completion:2026-04

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:ACTIVE_NOT_RECRUITING

Study ID

NCT07047209

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
1. Ability to provide written informed consent. 2. 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. 3. Available or pending CLIA certified ALS genetic panel report. 4. Less than or equal to 24-months since onset of weakness attributed to ALS. 5. Vital capacity (VC) of \> 65% predicted value for gender, height and age at screening. 6. Clinically unremarkable Complete Blood Counts, including but not limited to Hemoglobin ≥ 9 g/dL, Platelets ≥ 150 x 109 cells/L. 7. No clinically significant abnormalities in the Comprehensive Metabolic Panel per site/sub-investigator's judgment, including but not limited to: 1. Serum alanine aminotransferase or aspartate aminotransferase \< 3× upper limit of normal, or serum total bilirubin \<1.5× upper limit of normal 2. Estimated GFR (eGFR) of \> 30 mL/min/1.73m2 3. Other clinically significant electrolyte and metabolic abnormalities 8. Ability and willingness to complete all study procedures per the Site Investigator's clinical assessment. 9. 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). 10. 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.	* 1\. Clinically significant unstable medical or surgical condition that would pose a risk to the participant's trial procedural participation or interfere with data collection, according to the Site Investigator's judgment (e.g., active infection requiring antibiotics).

Inclusion Criteria

Exclusion Criteria

1. Ability to provide written informed consent.
2. 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.
3. Available or pending CLIA certified ALS genetic panel report.
4. Less than or equal to 24-months since onset of weakness attributed to ALS.
5. Vital capacity (VC) of \> 65% predicted value for gender, height and age at screening.
6. Clinically unremarkable Complete Blood Counts, including but not limited to Hemoglobin ≥ 9 g/dL, Platelets ≥ 150 x 109 cells/L.
7. No clinically significant abnormalities in the Comprehensive Metabolic Panel per site/sub-investigator's judgment, including but not limited to:
1. Serum alanine aminotransferase or aspartate aminotransferase \< 3× upper limit of normal, or serum total bilirubin \<1.5× upper limit of normal
2. Estimated GFR (eGFR) of \> 30 mL/min/1.73m2
3. Other clinically significant electrolyte and metabolic abnormalities
8. Ability and willingness to complete all study procedures per the Site Investigator's clinical assessment.
9. 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).
10. 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.

* 1\. Clinically significant unstable medical or surgical condition that would pose a risk to the participant's trial procedural participation or interfere with data collection, according to the Site Investigator's judgment (e.g., active infection requiring antibiotics).

Contacts and Locations

Study Locations (Sites)

Nova Southeastern University

Davie, Florida, 33314

United States

Northwestern Universsity

Chicago, Illinois, 60611

United States

MGH

Boston, Massachusetts, 02114

United States

Collaborators and Investigators

Sponsor: Massachusetts General Hospital

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-05-27

Study Completion Date2026-04

Study Record Updates

Study Start Date2025-05-27

Study Completion Date2026-04

Terms related to this study

Keywords Provided by Researchers

ALS
Amyotrophic Lateral Sclerosis
Early ALS

Additional Relevant MeSH Terms

ALS (Amyotrophic Lateral Sclerosis)