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NCT07142291 · ClinicalTrials.gov registry record · Phase 2

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

A Phase 2 study of Amyotrophic Lateral Sclerosis (ALS), sponsored by PhenoNet.

Recruiting
Registry status
Phase 2
Development phase
105
Enrollment target
12
Study locations

NCT07142291 is a Phase 2 study of Amyotrophic Lateral Sclerosis (ALS) that is actively recruiting participants, run by PhenoNet. The registered enrollment target is 105 participants, below the 255-participant average among 17 other Amyotrophic Lateral Sclerosis (ALS) trials with a reported enrollment target (59% lower). The trial reports 12 study locations across 5 states.

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The verdict

NCT07142291, a Phase 2 study of Amyotrophic Lateral Sclerosis (ALS), is actively recruiting participants, sponsored by PhenoNet.

RECRUITING
Registry status
Phase 2
Development phase
105 participants
Enrollment target
12
Study locations

Study 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.

Interventions

  • DRUG Placebo
  • DRUG Cromolyn Sodium (34.2 mg BID)
  • DRUG Cromolyn Sodium (17.1 mg BID)
  • DRUG Riluzole (100 mg)

Study Locations (12)

Other

  • Thomayer University Hospital - Fakultní Thomayerova nemocnice - Prague
  • Charité Centrum für Neurologie, Neurochirurgie und Psychiatrie - Berlin
  • Michalski i Partnerzy Lekarze Spółka Partnerska - Krakow
  • SP ZOZ Szpital Uniwersytecki w Krakowie - Krakow
  • Centrum Medyczne NeuroProtect (NeuroProtect Medical Center) - Warsaw
  • City Clinic Research - Warsaw
  • University Clinical Center of Serbia - Belgrade

California

  • University of California San Diego - La Jolla
  • Sutter Health - California Pacific Medical Center Research Institute - San Francisco

Arizona

  • Honor Health Neurology - Bob Bove Neuroscience Institute - Scottsdale

Florida

  • Mayo Clinic Jacksonville - Jacksonville

New York

  • Lange Neurology - New York

Trial Details

FieldValue
Enrollment Target 105 participants
Start Date 2025-11-25
Est. Completion 2028-03
Phase Phase 2

Sponsor

PhenoNet

1 total trials

What the Registry Record Tells You About NCT07142291

The ClinicalTrials.gov registry entry for NCT07142291 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 105 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 255-participant average among 17 other Amyotrophic Lateral Sclerosis (ALS) trials with a reported enrollment target (59% lower). The listed sponsor is PhenoNet, which has 1 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Amyotrophic Lateral Sclerosis (ALS) appearing as the primary indexed condition, and to 4 interventions - of which Placebo is the first listed.

NCT07142291 reports 12 study locations spanning 5 distinct geographic areas - top geographies include Other, California, Arizona.

Frequently Asked Questions

What is clinical trial NCT07142291 about?

NCT07142291 is a clinical study titled "PHENOGENE-1A (Cromolyn) Treatment in Patients With Mild to Moderate ALS". 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 fun...

What is the current status of trial NCT07142291?

This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 105 participants. The study started on 2025-11-25. Estimated completion is 2028-03.

What conditions does trial NCT07142291 study?

This clinical trial studies the following conditions: Amyotrophic Lateral Sclerosis (ALS).

What interventions are being tested in trial NCT07142291?

The interventions under investigation include: Placebo (DRUG), Cromolyn Sodium (34.2 mg BID) (DRUG), Cromolyn Sodium (17.1 mg BID) (DRUG), Riluzole (100 mg) (DRUG).

Who is sponsoring clinical trial NCT07142291?

This trial is sponsored by PhenoNet, which has 1 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT07142291 being conducted?

This trial has 12 study locations across Arizona, California, Florida, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.