A Phase IIb Randomized, Double-blind, Placebo-controlled, Multi-Dose Study to Evaluate the Effects of PHENOGENE-1a (Cromolyn) as an Adjuvant Treatment in Subjects with Mild to Moderate Amyotrophic Lateral Sclerosis (ALS)

Status

Not yet recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2025-520688-42-00

Acronym

PHENOALS-001

Enrollment

Registered

2025-10-21

Start date

Unknown

Completion date

Unknown

Last updated

2025-12-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Amyotrophic Lateral Sclerosis (ALS)

Brief summary

Absolute change in ALSFRS-R total score from baseline to Week 24.

Detailed description

Mean rank for CAFS across all by treatment group at Week 24., Time to event requiring full-time or nearly full-time respiratory support., Mean change in %FVC from baseline to Week 24., Mean change in PIFR from baseline to Week 24.

Interventions

DRUGPlacebo capsule

DRUGoral inhalation via DPI

DRUGPHENOGENE-1a

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Absolute change in ALSFRS-R total score from baseline to Week 24.	—

Secondary

Measure	Time frame
Mean rank for CAFS across all by treatment group at Week 24., Time to event requiring full-time or nearly full-time respiratory support., Mean change in %FVC from baseline to Week 24., Mean change in PIFR from baseline to Week 24.	—

Countries

Czechia, Germany, Poland, Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026