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Can an asthma drug slow ALS? new trial aims to find out

NCT ID NCT07142291

Disease control Sponsor: PhenoNet, Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jul 24, 2026 · Updated 4 times

Summary

This phase 2 trial is testing whether an inhaled drug called cromolyn (PHENOGENE-1A) can help people with mild-to-moderate ALS when added to standard care. About 105 participants will receive either a low dose, high dose, or placebo for 24 weeks. Researchers will measure changes in daily function, breathing, and safety.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Cromolyn sodium (PHENOGENE-1A) taken by oral inhalation twice daily
What this could lead to
If it works, this could slow functional decline in people with mild-to-moderate ALS, potentially adding months of better quality of life.
What could go wrong
This is an early phase 2 trial with only 105 people. It may fail to show benefit, and cromolyn's effects on ALS are unproven. Side effects from the inhaled drug are possible.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 105 people

The number the study aims to enrol. It can still change while the study runs.

Started

Nov 2025

Expected to finish

Jun 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 75 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Diagnosis of ALS; the diagnosis of ALS defined by revised El Escorial criteria as follows: 1. Evidence of lower motor neuron (LMN) degeneration by clinical, electrophysiological, or neuropathological examination. 2. Evidence of upper motor neuron (UMN) degeneration by clinical examination. 3. Progressive spread of symptoms or signs within a region or to other regions, as determined by clinical examination or the history of disease progression. 4. Absence of electrophysiological, neuroimaging, or pathological evidence of other diseases that might explain the UMN or LMN degeneration and exclusion of other causes. 2. Male or female subjects aged 18 to 75 years inclusive. 3. Must provide written informed consent for study-related procedures. 4. Must be capable of completing all study-related procedures, assessments, and visits in the judgment of Investigator. 5. Disease duration from ALS symptom onset of motor weakness ≤24 months. 6. ALSFRS-R total score ≥38 at screening visit. 7. ALSFRS-R Breathing subscore should be ≥9 at the time of screening. 8. ALSFRS-R Bulbar subscore should be ≥9 at the time of screening. 9. Forced vital capacity \>70% of predicted value. 10. PIFR ≥100 L/minute. 11. Must be receiving a stable dose of standard-of-care treatment Riluzole for 4-weeks before signing informed consent. 12. Female subjects who are of childbearing potential must agree to use of highly effective methods of contraception consistent with local regulations during the study, and for 3 months after the study drug administration. Examples include the following, but not limited to: 1. Combined (estrogen and progestogen containing) or progestogen-only hormonal contraceptives; 2. Intrauterine device or intrauterine hormone-releasing system; OR 3. Post-menopausal status must have experienced their last menstrual period minimum of 1 year prior to study drug administration; OR 4. Surgically sterilized. Female subject should be willing to not donate egg during the trial and for 3 months after the last dose of the study drug. 13. Male subjects who are sexually active with a female of childbearing potential must agree to use highly effective contraception as described above, or a combination of 2 acceptable methods of contraception (e.g., a barrier method along with a female partner using a hormonal contraceptive method), in accordance with local regulations, throughout the duration of the study, and for 3 months after the last dose of the study drug. (Male subject should be willing to not donate sperm during the trial and for 3 months after the last dose of the study drug.) Exclusion Criteria: 1. ALSFRS-R score change (decrease) by 2.5 or more points between the screening visit and Day 1 (baseline) score. 2. Bulbar onset ALS (\<9 bulbar subscore) 3. 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. 4. Any other significant neurological disorder which can interfere with study assessments, e.g., significant cognitive impairment and/or clinical dementia. 5. 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. 6. 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). 7. Any moderate-to-severe pulmonary disease or difficulty taking inhaled drugs. 8. Inability to tolerate the administration of an oral inhaled powder via DPI. 9. Has taken any investigational product within 30 days or 5 half lives of the drug, whichever is longer, prior to dosing. 10. Taking inhaled protein products on a chronic basis (such as insulin, parathyroid hormone, etc). 11. Subjects with a body weight of 32 kg or less, or a body mass index of \<17.5 or \>35.0 at time of screening. 12. Moderate-to-severe liver disease: aspartate aminotransferase (AST), alanine aminotransferase (ALT) \>3 times the upper limit of normal; total bilirubin \> 1.5 x ULN.; subjects with hepatic diseases such as hepatic cirrhosis, hepatic cancer and active hepatitis. 13. Moderate-to-severe renal disease: creatinine clearance \<45 mL/min/1.73 m2 (by Cockcroft-Gault calculation). 14. Any clinically significant disorder or laboratory abnormality that, in the Investigator's opinion, could interfere with the subject's participation in the study, place the subject at increased risk, or confound interpretation of the study results. 15. Pregnant or breast-feeding females.

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Conditions

The condition(s) this trial relates to.

amyotrophic lateral sclerosis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Amyotrophic lateral sclerosis (ALS)

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    22 sites in 6 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Barcelona Sea Hospital (Hospital Del Mar De Barcelona)

    RECRUITING

    Barcelona, 8003, Spain

  • Centrum Medyczne NeuroProtect (NeuroProtect Medical Center)

    RECRUITING

    Warsaw, 01-684, Poland

  • Charité Centrum für Neurologie, Neurochirurgie und Psychiatrie

    RECRUITING

    Berlin, 13353, Germany

  • City Clinic Research

    RECRUITING

    Warsaw, 02-473, Poland

  • DIAKOVERE Henriettenstift - Klinik für Neurologie und Klinische Neurophysiologie

    RECRUITING

    Hanover, 30171, Germany

  • Fakultni Nemocnice Hradec Kralove

    RECRUITING

    Hradec Králové, 50005, Czechia

  • Honor Health Neurology - Bob Bove Neuroscience Institute

    RECRUITING

    Scottsdale, Arizona, 85251, United States

  • Hospital General Universitario Dr. Balmis de Alicante

    RECRUITING

    Alicante, 3010, Spain

  • Hospital Regional Universitario De Malaga

    RECRUITING

    Málaga, 29010, Spain

  • Hospital Universitario Ramon Y Cajal

    RECRUITING

    Madrid, 28034, Spain

  • Hospital Universitario Vall D Hebron

    RECRUITING

    Barcelona, 8035, Spain

  • Hospital Universitario Virgen Del Rocio

    RECRUITING

    Seville, 41013, Spain

  • Lange Neurology

    RECRUITING

    New York, New York, 10065, United States

  • Mayo Clinic Jacksonville

    RECRUITING

    Jacksonville, Florida, 32224, United States

  • Michalski i Partnerzy Lekarze Spółka Partnerska

    RECRUITING

    Krakow, 31-426, Poland

  • NEUROHK s.r.o.

    RECRUITING

    Hradec Králové, 50002, Czechia

  • SP ZOZ Szpital Uniwersytecki w Krakowie

    RECRUITING

    Krakow, 51-503, Poland

  • Sutter Health - California Pacific Medical Center Research Institute

    RECRUITING

    San Francisco, California, 94115, United States

  • Thomayer University Hospital - Fakultni Thomayerova nemocnice

    RECRUITING

    Prague, 14059, Czechia

  • Universitaetsklinikum Schleswig-Holstein

    RECRUITING

    Lübeck, 23538, Germany

  • University Clinical Center of Serbia

    RECRUITING

    Belgrade, 11000, Serbia

  • University of California San Diego

    RECRUITING

    La Jolla, California, 92037, United States

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Other studies related to the condition(s) this trial covers.