Digoxin for ALS
(ACACIA Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests digoxin to determine its safety and effectiveness in slowing the progression of ALS, a disease affecting nerve cells in the brain and spinal cord. Researchers aim to discover if digoxin can protect nerve cells from damage. Suitable candidates for this trial have been diagnosed with ALS within the last two years and have experienced muscle weakness due to the condition. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to potential advancements in ALS treatment.
Do I have to stop taking my current medications for the trial?
The trial does not specify if you need to stop taking your current medications, but you cannot take amiodarone or more than 20 mg/day of quinidine. If you're on investigational treatments for ALS, you must stop them at least 30 days or 5 half-lives before the trial, whichever is longer.
Is there any evidence suggesting that digoxin is likely to be safe for humans?
Research has shown that digoxin is usually well-tolerated. Studies have used it safely for various health issues, suggesting it might also be safe for people with ALS. Although specific information on side effects in ALS patients is not yet available, digoxin is already approved for treating heart conditions, indicating it has passed safety tests for those uses. However, monitoring for any new side effects in people with ALS remains important. Prospective trial participants will have their safety and any side effects closely monitored by the research team.12345
Why do researchers think this study treatment might be promising for ALS?
Digoxin is unique in the treatment of ALS because it offers a novel approach compared to standard options like Riluzole and Edaravone. Most current treatments aim to slow disease progression by reducing glutamate toxicity or oxidative stress. However, Digoxin works differently by affecting cellular ion balance, which could potentially stabilize nerve cells and preserve their function. Researchers are excited because this distinct mechanism might offer additional benefits and enhance the quality of life for those living with ALS.
What evidence suggests that digoxin might be an effective treatment for ALS?
Research suggests that digoxin, the treatment under study in this trial, might slow nerve damage in ALS (Amyotrophic Lateral Sclerosis). Although few studies focus specifically on digoxin for ALS, it is known to affect cell functions in ways that could protect nerve cells. Digoxin has been used for heart conditions, demonstrating its influence on cellular functions. The hope is that these effects might also help slow ALS progression. However, more research is needed to confirm its effectiveness for ALS.25678
Are You a Good Fit for This Trial?
This trial is for individuals with Amyotrophic Lateral Sclerosis (ALS), also known as Lou Gehrig's Disease. Specific eligibility criteria are not provided, but typically participants must meet certain health standards and may be required to have a confirmed diagnosis of ALS.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive oral digoxin for 24 weeks to evaluate safety, tolerability, and biological efficacy
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Digoxin
Find a Clinic Near You
Who Is Running the Clinical Trial?
Massachusetts General Hospital
Lead Sponsor