Trial · NCT07142291
PHENOGENE-1A (Cromolyn) Treatment in Patients With Mild to Moderate ALS
NCT07142291, Phase 2, Recruiting, PhenoNet, Inc.
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. PHENOGENE-1A (Cromolyn) Treatment in Patients With Mild to Moderate ALS. Trials, record NCT07142291. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07142291
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- PHENOGENE-1A (Cromolyn) Treatment in Patients With Mild to Moderate ALS
- NCT number
- NCT07142291
- Status
- Recruiting
- Phases
- Phase 2
- Enrollment
- 105 participants, estimated
- Lead sponsor
- PhenoNet, Inc.
- Conditions
- Amyotrophic Lateral Sclerosis (ALS)
- Interventions
- Cromolyn Sodium (34.2 mg BID), Cromolyn Sodium (17.1 mg BID), Placebo, Riluzole (100 mg)
- First posted
- 2025-08-26
- Last updated
- 2026-07-23
Source ClinicalTrials.gov
Registered outcomes14
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Absolute change in ALSFRS-R total score from baseline to Week 24 | Baseline to Week 24 | To evaluate the effects of PHENOGENE-1A (cromolyn) on functional changes in subjects with mild to moderate ALS using the ALS Functional Rating Scale-Revised (ALSFRS-R). |
| Primary | Incidence and severity of treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) | Baseline to Week 24 | To evaluate the safety of PHENOGENE-1A following 24 weeks of twice daily (BID) treatment. |
| Secondary | Mean rank for CAFS at Week 24 | Baseline to Week 24 | To evaluate the effects of PHENOGENE-1A on function and survival using the Combined Assessment of Function and Survival (CAFS). |
| Secondary | Time to event requiring full-time or nearly full-time respiratory support | Randomization to Week 24 | Time from randomization to the first of 7 consecutive days on which permanent assisted ventilation (invasive or non-invasive) was used for \>22 hours/day due to ALS progression. |
| Secondary | Mean change in percent predicted forced vital capacity (%FVC) from baseline to Week 24 | Baseline to Week 24 | To evaluate the effect of PHENOGENE-1A on respiratory changes. |
| Secondary | Mean change in peak inspiratory flow rate (PIFR) from baseline to Week 24 | Baseline to Week 24 | To evaluate changes in PIFR (L/min) during treatment. |
| Secondary | Absolute Values and Changes From Baseline in Vital Signs From Baseline to Week 24 by Treatment Arm | Baseline to Week 24 | Vital signs will include: * Systolic blood pressure (mmHg) * Diastolic blood pressure (mmHg) * Pulse rate (beats per minute) * Respiratory rate (breaths per minute) * Body temperature (°C or °F, as recorded) Results will be summarized as: * Absolute values for each parameter at each scheduled visit. * Changes from baseline at each visit. * Summaries will be presented separately by treatment arm. |
| Secondary | Number and Percentage of Subjects With Abnormal Clinical Laboratory Values and Changes From Baseline to Week 24 by Treatment Arm | Baseline to Week 24 | Safety laboratory assessments will include hematology, clinical chemistry, coagulation, and urinalysis panels. Each laboratory result will be classified as normal, abnormal (not clinically significant), or abnormal (clinically significant). Results will be summarized as: Number and percentage of subjects with abnormal laboratory values at each post-baseline visit, by treatment arm. Summary statistics for absolute values and changes from baseline at each visit. |
| Secondary | Number and Percentage of Subjects With Abnormal Physical Examination Findings From Baseline to Week 24 by Treatment Arm | Baseline to Week 24 | The physical examination will assess head/neck, eyes, ears, nose/throat, cardiovascular, respiratory, abdominal, musculoskeletal, extremities, and skin systems. Each system will be classified as normal, abnormal (not clinically significant), or abnormal (clinically significant). Results will be summarized as the number and percentage of subjects with abnormal findings at each post-baseline visit. |
| Secondary | Number and Percentage of Subjects With Abnormal Neurological Examination Findings From Baseline to Week 24 by Treatment Arm | Baseline to Week 24 | The neurological examination will assess mental status, motor function, sensory function, reflexes, and coordination/cerebellar function. Each domain will be classified as normal, abnormal (not clinically significant), or abnormal (clinically significant). Results will be summarized as the number and percentage of subjects with abnormal findings at each post-baseline visit. |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 registered outcomesOutcomes0
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/NCT07142291
GET https://conductscience.org/api/trials/v1/NCT07142291/registered