A Study on the Addition of Alsum30 for the Treatment of Amyotrophic Lateral Sclerosis
NCT07922031, Not applicable, Not yet recruiting, Liu Qing
Trial 10
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | A Study on the Addition of Alsum30 for the Treatment of Amyotrophic Lateral Sclerosis | ClinicalTrials.gov |
| NCT number | NCT07922031 | ClinicalTrials.gov |
| Status | Not yet recruiting | ClinicalTrials.gov |
| Phases | Not applicable | ClinicalTrials.gov |
| Enrollment | 15 participants, estimated | ClinicalTrials.gov |
| Lead sponsor | Liu Qing | ClinicalTrials.gov |
| Conditions | Amyotrophic Lateral Sclerosis (ALS), Bacillus Coagulans, Dietary Supplement, Sulforaphane | ClinicalTrials.gov |
| Interventions | Sulforaphane and Bacillus coagulans GBI-30, 6086 | ClinicalTrials.gov |
| First posted | 2026-11-06 | ClinicalTrials.gov |
| Last updated | 2026-11-06 | ClinicalTrials.gov |
Registered outcomes 15
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Number of Participants With Treatment-Emergent Adverse Events | From first dose through 4 weeks after the last dose | The number of participants with at least one adverse event that begins or worsens after the first dose of Alsum30. Events will be graded according to the Common Terminology Criteria for Adverse Events, version 5.0 (CTCAE v5.0). Incidence and severity will be summarized. | ClinicalTrials.gov |
| Primary | Number of Participants With Serious Adverse Events | From first dose through 4 weeks after the last dose | The number of participants with at least one serious adverse event during the safety observation period. | ClinicalTrials.gov |
| Primary | Number of Participants Who Discontinue Study Treatment Early | From first dose through Week 24 | The number of participants who permanently discontinue Alsum30 before completing the planned 24-week treatment period, for any reason. | ClinicalTrials.gov |
| Primary | Number of Participants Who Discontinue Study Treatment Early Due to Adverse Events | From first dose through Week 24 | The number of participants who permanently discontinue Alsum30 before completing the planned 24-week treatment period because of an adverse event. | ClinicalTrials.gov |
| Primary | Number of Participants With Clinically Significant Laboratory Abnormalities | Baseline (Week 0) and Weeks 4, 12, 24, and 28 | The number of participants with a new or worsening laboratory abnormality after the first dose that the investigator judges to be clinically significant. Scheduled safety laboratory assessments include hematology, liver function, renal function, coagulation, C-reactive protein, muscle enzymes, and fasting glucose. | ClinicalTrials.gov |
| Secondary | Change From Baseline in ALS Functional Rating Scale-Revised Total Score | Week -6, baseline (Week 0), and Weeks 4, 12, and 24 | Change from the Week 0 score at each post-baseline assessment. The ALS Functional Rating Scale-Revised (ALSFRS-R) total score ranges from 0 to 48; higher scores indicate better function. A Week -6 assessment is collected during the pretreatment run-in period. | ClinicalTrials.gov |
| Secondary | Change From Baseline in Forced Vital Capacity Percent Predicted | Week -6, baseline (Week 0), and Weeks 4, 12, and 24 | Change from the Week 0 value in forced vital capacity, expressed as a percentage of the predicted value (FVC%). | ClinicalTrials.gov |
| Secondary | Change From Baseline in Slow Vital Capacity Percent Predicted | Week -6, baseline (Week 0), and Weeks 4, 12, and 24 | Change from the Week 0 value in slow vital capacity, expressed as a percentage of the predicted value (SVC%). | ClinicalTrials.gov |
| Secondary | Percentage of Participants Alive at Week 24 | From first dose through Week 24 | The percentage of participants who are alive 24 weeks after starting study treatment. | ClinicalTrials.gov |
| Secondary | Percentage of Participants Alive Without Respiratory Insufficiency at Week 24 | From first dose through Week 24 | The percentage of participants who have neither died nor developed respiratory insufficiency by Week 24. Respiratory insufficiency is defined as tracheostomy or use of noninvasive ventilation for at least 22 hours per day for at least 10 consecutive days. | ClinicalTrials.gov |
| Secondary | Percentage of Participants Alive Without Respiratory Insufficiency or ALS-Related Hospitalization at Week 24 | From first dose through Week 24 | The percentage of participants who, by Week 24, have not died, developed respiratory insufficiency, or been hospitalized because of an amyotrophic lateral sclerosis (ALS)-related complication. Respiratory insufficiency is defined as tracheostomy or use of noninvasive ventilation for at least 22 hours per day for at least 10 consecutive days. | ClinicalTrials.gov |
| Secondary | Change From Baseline in ALS Assessment Questionnaire-40 Domain Scores | Week -6, baseline (Week 0), and Weeks 4, 12, and 24 | Change from Week 0 in the five ALS Assessment Questionnaire-40 (ALSAQ-40) domain scores: physical mobility, activities of daily living and independence, eating and drinking, communication, and emotional reactions. Each domain is scored from 0 to 100; higher scores indicate worse health status. A Week -6 assessment is collected during the pretreatment run-in period. | ClinicalTrials.gov |
| Other | Change From Baseline in Edinburgh Cognitive and Behavioural ALS Screen Total Score | Week -6, baseline (Week 0), and Weeks 4, 12, and 24 | Change from the Week 0 Edinburgh Cognitive and Behavioural ALS Screen (ECAS) cognitive total score. The total score ranges from 0 to 136; higher scores indicate better cognitive performance. A Week -6 assessment is collected during the pretreatment run-in period. | ClinicalTrials.gov |
| Other | Change From Baseline in Plasma Neurofilament Light Chain Concentration | Baseline (Week 0) and Weeks 4, 12, and 24 | Change from the Week 0 concentration of plasma neurofilament light chain (NfL) at each post-baseline assessment. | ClinicalTrials.gov |
| Other | Change From Baseline in Plasma Glial Fibrillary Acidic Protein Concentration | Baseline (Week 0) and Weeks 4, 12, and 24 | Change from the Week 0 concentration of plasma glial fibrillary acidic protein (GFAP) at each post-baseline assessment. | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|
Adverse events 0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|
Papers 0
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
|---|
Grants 0
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.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.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.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)