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
Trial Overview
The trial is testing the safety and tolerability of an oral medication called digoxin in people with ALS. It will also explore whether digoxin can slow down the progression of neurodegeneration associated with this condition.
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
Find a Clinic Near You
Who Is Running the Clinical Trial?
Massachusetts General Hospital
Lead Sponsor
Citations
PMC - PubMed Central
We found 10 drugs significantly associated with lower ALS risk after the multiple-testing correction in a one-year and three-year lag analysis.
2.
centerwatch.com
centerwatch.com/clinical-trials/listings/NCT07047209/trial-of-oral-digoxin-in-individuals-with-amyotrophic-lateral-sclerosis-alsTrial of Oral Digoxin in Individuals With Amyotrophic ...
Additionally, this trial aims to better understand if digoxin has an effect on slowing neurodegeneration in ALS. Eligibility Criteria. Inclusion.
Trial of Oral Digoxin in Individuals With Amyotrophic ...
This clinical trial is being conducted to learn about safety and tolerability of digoxin in ALS individuals. Additionally, this trial aims to better understand ...
Plasma, brain and spinal cord concentrations of caffeine ...
Plasma, brain and spinal cord concentrations of caffeine are reduced in the SOD1G93A mouse model of amyotrophic lateral sclerosis following oral administration.
ALS MyMatch Webinar- ACACIA: Trial of Oral Digoxin in ALS
Join us on June 9th, 11:00am ET for a webinar introducing the first Healey ALS MyMatchclinical trial- the ACACIA trial of oral digoxin.
Trial of Oral Digoxin in Individuals With Amyotrophic ...
This clinical trial is being conducted to learn about safety and tolerability of digoxin in ALS individuals. Additionally, this trial aims to better ...
Digoxin for ALS · Info for Participants
... Digoxin will have tolerable side effects & efficacy for patients with Amyotrophic Lateral Sclerosis and Lou Gehrig's Disease. Learn more about the study.
Medication use and risk of amyotrophic lateral sclerosis—a ...
It appeared that statins, aspirin, OCs/HRT, antihypertensives, and antidiabetics were unlikely related to a higher risk of ALS.
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