RecruitingPhase 2NCT07142291

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

A Phase IIB Randomized, Double-Blind, Placebo-Controlled, Multi-Dose Study to Evaluate the Effects of PHENOGENE-1A (Cromolyn) as an Adjuvant Treatment in Subjects With Mild to Moderate Amyotrophic Lateral Sclerosis (ALS)


Sponsor

PhenoNet, Inc.

Enrollment

105 participants

Start Date

Nov 25, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

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

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether an inhaled form of cromolyn sodium (called PHENOGENE-1A) can slow the progression of ALS (amyotrophic lateral sclerosis, also known as Lou Gehrig's disease). The drug works by targeting immune cells called mast cells that may contribute to nerve damage in ALS. **You may be eligible if...** - You are between 18 and 75 years old and have a confirmed diagnosis of ALS - Your symptoms of muscle weakness started within the past 24 months - Your ALS is not too advanced (functional score of 38 or above, breathing capacity above 70%) - You are currently on a stable dose of riluzole (standard ALS medication) - You do not require any breathing assistance **You may NOT be eligible if...** - Your ALS primarily affects your speech or swallowing (bulbar onset) - You require any form of breathing support (CPAP, BiPAP, oxygen) - You have a significant heart condition (e.g., QT prolongation, severe heart failure) - You have moderate to severe lung, liver, or kidney disease - You are very underweight (BMI below 17.5) or over 35 BMI - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGCromolyn Sodium (34.2 mg BID)

17.1 mg, BID, oral inhalation

DRUGCromolyn Sodium (17.1 mg BID)

34.2 mg, BID, oral inhalation via dry powder inhaler

DRUGPlacebo

Placebo comparator matched to active treatment.

DRUGRiluzole (100 mg)

50 mg, oral tablet, BID, standard of care treatment


Locations(17)

Honor Health Neurology - Bob Bove Neuroscience Institute

Scottsdale, Arizona, United States

University of California San Diego

La Jolla, California, United States

Sutter Health - California Pacific Medical Center Research Institute

San Francisco, California, United States

Mayo Clinic Jacksonville

Jacksonville, Florida, United States

Lange Neurology

New York, New York, United States

NEUROHK s.r.o.

Hradec Králové, Czechia

Thomayer University Hospital - Fakultni Thomayerova nemocnice

Prague, Czechia

Charité Centrum für Neurologie, Neurochirurgie und Psychiatrie

Berlin, Germany

DIAKOVERE Henriettenstift - Klinik für Neurologie und Klinische Neurophysiologie

Hanover, Germany

Universitaetsklinikum Schleswig-Holstein

Lübeck, Germany

Michalski i Partnerzy Lekarze Spółka Partnerska

Krakow, Poland

SP ZOZ Szpital Uniwersytecki w Krakowie

Krakow, Poland

Centrum Medyczne NeuroProtect (NeuroProtect Medical Center)

Warsaw, Poland

City Clinic Research

Warsaw, Poland

University Clinical Center of Serbia

Belgrade, Serbia

Hospital Universitario Vall D Hebron

Barcelona, Spain

Hospital Universitario Ramon Y Cajal

Madrid, Spain

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

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NCT07142291


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