PHENOGENE-1A (Cromolyn) Treatment in Patients With Mild to Moderate ALS

ConditionAmyotrophic Lateral Sclerosis (ALS)

Trial statusRecruiting

Trial phasePhase 2

Trial typeInterventional

Biological sexAll

Age18-75

SponsorPhenoNet, Inc.

About this trial

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.

Eligibility criteria

Qualifiers

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.

Disqualifiers

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.