Testing a new inhaled medication as add-on treatment for early-stage ALS

Plain-English translation of NCT07142291 on ClinicalTrials.gov ↗ · Source last updated June 2026 · Translation generated June 2026 · How we translate trials

Phase 2 — Testing in a bigger group (up to a few hundred people) to see if the treatment actually works and is still safe.

What is this trial?

This trial is testing whether PHENOGENE-1A (Cromolyn), an inhaled medication, can help slow the progression of ALS when used alongside the standard ALS drug Riluzole. About 105 people with mild to moderate ALS will receive either a low dose, high dose, or placebo version of the medication by inhalation twice daily for 24 weeks. The study will measure whether this treatment helps preserve strength, breathing, and swallowing function.

ALS is a progressive disease with limited treatment options, and Riluzole alone does not stop the disease from getting worse. This trial is exploring whether this medication might offer additional benefit by reducing inflammation or protecting nerve cells, potentially slowing disease progression.

Do you qualify?

You likely qualify if…

you have been diagnosed with ALS according to standard diagnostic criteria
you are aged 18 to 75 years old
you have had ALS symptoms for 24 months or less
you have been taking a stable dose of Riluzole (the standard ALS medication) for at least 4 weeks before enrolling
your breathing, swallowing, and overall function scores are in a mild to moderate range on standard ALS tests

You likely don't qualify if…

your ALS symptoms are worsening very rapidly (declining by 2.5 or more points on the standard ALS scale between screening and the start date)
your ALS started in the bulbar region (throat and swallowing muscles) with severe loss of swallowing function
you are currently using non-invasive ventilation (breathing machines like BiPAP or CPAP)
your lung function is below 70% of expected for your age and body size
you are unable to complete all study visits and procedures as required

What participation looks like

You would visit the study clinic regularly over 24 weeks while continuing your regular Riluzole medication. At each visit, researchers would assess your strength, breathing, and swallowing using standard tests. You would use a dry powder inhaler device twice daily at home to inhale either the test medication or placebo. You would also complete breathing tests and answer questions about your symptoms and quality of life.

AI-generated summary from trial data · Jun 12, 2026 · Not medical advice

Trial locations(20 sites)

United States

Honor Health Neurology - Bob Bove Neuroscience Institute, Scottsdale, Arizona

University of California San Diego, La Jolla, California

Sutter Health - California Pacific Medical Center Research Institute, San Francisco, California

Mayo Clinic Jacksonville, Jacksonville, Florida

Lange Neurology, New York, New York