NCT07142291
PHENOGENE-1A (Cromolyn) Treatment in Patients With Mild to Moderate ALS
Recruiting · Phase 2 · PhenoNet, Inc. · registry updated 2026-07-23
Inclusion and exclusion lines below are quoted from ClinicalTrials.gov. No match score is shown, because a score needs a person's age, biomarkers, and treatment dates. Confirm the record with the study team.
The purpose of this study is to test the effects of PHENOGENE-1A, which is the treatment under investigation in this study. This research will investigate if PHENOGENE-1A can help people with ALS by measuring their function using the ALS Functional Rating Scale Revised (ALSFRS-R), measuring lung function using pulmonary function tests (PFTs), such as forced vital capacity (FVC), and measuring neuro-inflammatory biomarkers in the blood.
Inclusion
- Diagnosis of ALS; the diagnosis of ALS defined by revised El Escorial criteria as follows:
- Evidence of lower motor neuron (LMN) degeneration by clinical, electrophysiological, or neuropathological examination.
- Evidence of upper motor neuron (UMN) degeneration by clinical examination.
- Progressive spread of symptoms or signs within a region or to other regions, as determined by clinical examination or the history of disease progression.
- Absence of electrophysiological, neuroimaging, or pathological evidence of other diseases that might explain the UMN or LMN degeneration and exclusion of other causes.
- Male or female subjects aged 18 to 75 years inclusive.
Exclusion
- ALSFRS-R score change (decrease) by 2.5 or more points between the screening visit and Day 1 (baseline) score.
- Bulbar onset ALS (\<9 bulbar subscore)
- Any use of non-invasive ventilation (e.g., continuous positive airway pressure, non-invasive bi-level positive airway pressure or non-invasive volume ventilation) for any portion of the day, or mechanical ventilation via tracheostomy, or on any form of oxygen supplementation.
- Any other significant neurological disorder which can interfere with study assessments, e.g., significant cognitive impairment and/or clinical dementia.
- Significant psychiatric illness like schizophrenia, bipolar disorder etc. Subjects with depression can be included, only if the depression has been stable and no episode of major depression has occurred in the past year.
- Severe cardiac disease (e.g., QTc\>500 ms), Torsade de Pointes, evidence of significant heart failure (New York Heart Association \[NYHA\] Class 3 or greater, myocardial infarction or unstable angina in the 6 months prior to screening).