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

Part of paid clinical trials in Scottsdale, Arizona.

Sponsor
PhenoNet, Inc.
Study ID
NCT07142291
Phase
PHASE2
Status
Recruiting
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Conditions

  • Amyotrophic Lateral Sclerosis (ALS)

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Cromolyn Sodium (34.2 mg BID) — DRUG
    17.1 mg, BID, oral inhalation
  • Cromolyn Sodium (17.1 mg BID) — DRUG
    34.2 mg, BID, oral inhalation via dry powder inhaler
  • Placebo — DRUG
    Placebo comparator matched to active treatment.
  • Riluzole (100 mg) — DRUG
    50 mg, oral tablet, BID, standard of care treatment

Study Details

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.

Key Dates

Start date
Nov 25, 2025
Status verified
Jun 2026
Primary completion
Mar 31, 2027
Completion
Jun 30, 2027

Study Design

Enrollment
105 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Low Dose PHENOGENE-1A (17.1 mg BID)
    17.1 mg, BID, oral inhalation via dry powder inhaler
  • Experimental: High Dose PHENOGENE-1A (34.2 mg BID)
    34.2 mg, BID, oral inhalation via dry powder inhaler
  • Placebo Comparator: Placebo
    Placebo comparator matched to active treatment, BID, oral inhalation via dry powder inhaler

Primary Outcome Measure

Absolute change in ALSFRS-R total score from baseline to Week 24 [ Time Frame: Baseline to Week 24 ]

Central Contacts

Locations (5)

FacilityCityStateZIPSite coordinators
Honor Health Neurology - Bob Bove Neuroscience InstituteScottsdaleArizona85251-
University of California San DiegoLa JollaCalifornia92037-
Sutter Health - California Pacific Medical Center Research InstituteSan FranciscoCalifornia94115-
Mayo Clinic JacksonvilleJacksonvilleFlorida32224-
Lange NeurologyNew YorkNew York10065-

Find similar trials in Scottsdale, AZ

By research site
Honor Health Neurology - Bob Bove Neuroscience Institute· Scottsdale, AZUniversity of California San Diego· La Jolla, CASutter Health - California Pacific Medical Center Research Institute· San Francisco, CAMayo Clinic Jacksonville· Jacksonville, FLLange Neurology· New York, NY

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