Actively Recruiting
PHENOGENE-1A (Cromolyn) Treatment in Patients With Mild to Moderate ALS
Led by PhenoNet, Inc. · Updated on 2026-04-01
105
Participants Needed
17
Research Sites
118 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
PHENOGENE-1A (Cromolyn) Treatment in Patients With Mild to Moderate ALS
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of ALS based on revised El Escorial criteria with evidence of upper and lower motor neuron degeneration and progressive symptom spread
- Male or female aged 18 to 75 years inclusive
- Written informed consent provided
- Capable of completing all study procedures and visits
- ALS symptom duration of motor weakness 24 months or less
- ALSFRS-R total score of 38 or higher at screening
- ALSFRS-R Breathing subscore of 9 or higher at screening
- ALSFRS-R Bulbar subscore of 9 or higher at screening
- Forced vital capacity greater than 70% of predicted value
- Peak inspiratory flow rate 100 L/min or higher
- Stable Riluzole dose for at least 4 weeks before consent and during treatment
- For females of childbearing potential, use of effective contraception during and for 3 months after study
- For males sexually active with females of childbearing potential, use of effective contraception during and for 3 months after study
You will not qualify if you...
- ALSFRS-R score decrease of 2.5 or more points between screening and baseline
- Bulbar onset ALS with bulbar subscore below 9
- Use of any non-invasive ventilation, mechanical ventilation, or oxygen supplementation
- Other significant neurological disorders affecting assessments
- Significant psychiatric illness except stable depression
- Severe cardiac disease or recent heart attack/unstable angina
- Moderate-to-severe pulmonary disease or difficulty with inhaled drugs
- Unable to tolerate oral inhaled powder via dry powder inhaler
- Use of investigational products within 30 days or 5 half-lives prior to dosing
- Chronic use of inhaled protein products
- Body weight 32 kg or less or BMI below 17.5 or above 35 at screening
- Moderate-to-severe liver disease or active liver conditions
- Moderate-to-severe renal disease with creatinine clearance below 45 mL/min/1.73 m2
- Any other significant medical condition or lab abnormality increasing risk or interfering with study
- Pregnant or breastfeeding females
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 17 locations
1
Honor Health Neurology - Bob Bove Neuroscience Institute
Scottsdale, Arizona, United States, 85251
Actively Recruiting
2
University of California San Diego
La Jolla, California, United States, 92037
Actively Recruiting
3
Sutter Health - California Pacific Medical Center Research Institute
San Francisco, California, United States, 94115
Actively Recruiting
4
Mayo Clinic Jacksonville
Jacksonville, Florida, United States, 32224
Actively Recruiting
5
Lange Neurology
New York, New York, United States, 10065
Actively Recruiting
6
NEUROHK s.r.o.
Hradec Králové, Czechia, 50002
Actively Recruiting
7
Thomayer University Hospital - Fakultni Thomayerova nemocnice
Prague, Czechia, 14059
Actively Recruiting
8
Charité Centrum für Neurologie, Neurochirurgie und Psychiatrie
Berlin, Germany, 13353
Actively Recruiting
9
DIAKOVERE Henriettenstift - Klinik für Neurologie und Klinische Neurophysiologie
Hanover, Germany, 30171
Actively Recruiting
10
Universitaetsklinikum Schleswig-Holstein
Lübeck, Germany, 23538
Actively Recruiting
11
Michalski i Partnerzy Lekarze Spółka Partnerska
Krakow, Poland, 31-426
Actively Recruiting
12
SP ZOZ Szpital Uniwersytecki w Krakowie
Krakow, Poland, 51-503
Actively Recruiting
13
Centrum Medyczne NeuroProtect (NeuroProtect Medical Center)
Warsaw, Poland, 01-684
Actively Recruiting
14
City Clinic Research
Warsaw, Poland, 02-473
Actively Recruiting
15
University Clinical Center of Serbia
Belgrade, Serbia, 11000
Actively Recruiting
16
Hospital Universitario Vall D Hebron
Barcelona, Spain, 8035
Actively Recruiting
17
Hospital Universitario Ramon Y Cajal
Madrid, Spain, 28034
Actively Recruiting
Research Team
D
David R Elmaleh, PhD
CONTACT
A
Atul Gupta, M.D.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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