Trial · NCT07047209
Trial of Oral Digoxin in Individuals With Amyotrophic Lateral Sclerosis (ALS)
NCT07047209, Phase 2, Completed, Massachusetts General Hospital
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Trial of Oral Digoxin in Individuals With Amyotrophic Lateral Sclerosis (ALS). Trials, record NCT07047209. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07047209
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Trial of Oral Digoxin in Individuals With Amyotrophic Lateral Sclerosis (ALS)
- NCT number
- NCT07047209
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 41 participants, actual
- Lead sponsor
- Massachusetts General Hospital
- Conditions
- ALS (Amyotrophic Lateral Sclerosis)
- Interventions
- Digoxin
- First posted
- 2025-07-02
- Last updated
- 2026-07-30
Source ClinicalTrials.gov
Registered outcomes10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Incidence of Treatment-Emergent Adverse Events [Safety] | From drug initiation through study completion, an average of 28 weeks | Safety: Defined as the occurrence of serious and non-serious treatment-emergent adverse events (TEAEs) and clinically significant treatment-emergent abnormalities in clinical and laboratory values including digoxin trough levels, in ALS individuals treated with study treatment. |
| Primary | Incidence of Completing Study Treatment [Tolerability] | From drug initiation through study completion, an average of 28 weeks | Tolerability: Defined as percentage of ALS participants who complete the 24 weeks of study treatment, without study drug-attributed intolerable AEs that lead to early permanent drug discontinuation. |
| Secondary | Biological Efficacy | From enrollment to the end of study treatment at the Week 24 Visit | Biological Efficacy: Changes from baseline at week 24 in blood neurofilament light (NfL) levels following oral digoxin treatment. |
| Secondary | CNS Penetrance | From enrollment to end of study treatment at the Week 24 Visit | CNS Penetrance: Defined as CSF digoxin level measurement over 24 weeks of treatment. |
| Other | ALS Functional Rating Scale Revised (ALSFRS-R) total and sub-domain scores. | From enrollment to the end of study treatment at the Week 24 Visit | Changes from baseline at Week 12 and Week 24 in ALS Functional Rating Scale Revised (ALSFRS-R) total and sub-domain scores. The 12 domains included in the ALSFRS-R are rated on a 5-point scale, 0 to 4, with a maximum score of 48 indicating the highest level of functioning. |
| Other | Slow vital capacity (SVC) | From enrollment to the end of study treatment at the Week 24 Visit | Changes from baseline at Week 12 and Week 24 in SVC. |
| Other | Quality of Life measure: ALSAQ-40 total score | From enrollment to the end of study treatment at the Week 24 Visit | Changes from baseline at Week 12 and Week 24 in ALSAQ-40 scores. |
| Other | Permanent assisted ventilation-free survival | Permanent assisted ventilation is defined as use of non-invasive or invasive ventilation for >22 hours in a 24-hour period, for 7 consecutive days. | Changes from baseline at Week 12 and Week 24 in Permanent assisted ventilation-free survival. |
| Other | Threshold Nerve Conduction Studies | From enrollment to the end of study treatment at the Week 24 Visit. | Participants at the MGH site will participate in threshold tracking nerve excitability. Evaluate changes from baseline at Week 12 and Week 24 in the electrophysiological endpoints. |
| Other | CSF analyses of Poly(GP) | From enrollment to the end of study treatment at the Week 24 Visit. | Fold change from baseline at Week 12 and Week 24 in CSF analyses of biomarkers including poly(GP). |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT07047209
GET https://conductscience.org/api/trials/v1/NCT07047209/registered