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

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 296-participant average among 18 other Amyotrophic Lateral Sclerosis (ALS) trials with a reported enrollment target (65% lower). The trial reports 12 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.

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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.

Primary Outcome

To evaluate the effects of PHENOGENE-1A (cromolyn) on functional changes in subjects with mild to moderate ALS using the ALS Functional Rating Scale-Revised (ALSFRS-R).

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
PhenoNet

1 total trials

What NCT07142291 shows while recruiting

NCT07142291 is an interventional study that assigns participants to a tested intervention. The registered 105 participants enrollment target is mid-sized for trials with a published cap, below the 296-participant average among 18 other Amyotrophic Lateral Sclerosis (ALS) trials with a reported enrollment target (65% lower).

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 lists 12 locations in 5 states (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.

Similar trials for Amyotrophic Lateral Sclerosis (ALS)

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT07142291's enrollment target sits among peer trials

105 8th of 18 higher than 11 of 18 other Amyotrophic Lateral Sclerosis (ALS) trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Amyotrophic Lateral Sclerosis (ALS) trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT07142291, the US trial registry maintained by the National Library of Medicine. NCT07142291 (mid enrollment · multi site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.