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

NCT07142291 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 105

Last updated 2026-04-01

No results posted yet for this 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.

Conditions

  • Amyotrophic Lateral Sclerosis (ALS)

Interventions

DRUG

Cromolyn Sodium (34.2 mg BID)

17.1 mg, BID, oral inhalation

DRUG

Cromolyn Sodium (17.1 mg BID)

34.2 mg, BID, oral inhalation via dry powder inhaler

DRUG

Placebo

Placebo comparator matched to active treatment.

DRUG

Riluzole (100 mg)

50 mg, oral tablet, BID, standard of care treatment

Sponsors & Collaborators

  • PhenoNet, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-11-25
Primary Completion
2027-11-30
Completion
2028-03-31
FDA Drug
Yes

Countries

  • United States
  • Czechia
  • Germany
  • Poland
  • Serbia
  • Spain

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07142291 on ClinicalTrials.gov