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Sodium Cromoglicate

Questo articolo riassume gli studi clinici su Sodium Cromoglicate. Le sperimentazioni valutano soprattutto efficacia e sicurezza in persone con sclerosi multipla e sclerosi laterale amiotrofica (ALS). I trial sono di fase 2 e misurano sintomi come la fatica e la funzione fisica.

Table of contents

Trial overview

The available data describe two interventional studies of Sodium Cromoglicate, both in phase 2 and both marked as Authorised.[1][2]

One study is in people with multiple sclerosis, and the other is in people with amyotrophic lateral sclerosis (ALS).[1][2]

Multiple sclerosis study

The first trial, 2023-507541-29-00, is titled “Efficacy and safety of cromoglycate as a new symptomatic treatment in patients with multiple sclerosis.”[1]

This study includes 120 participants and compares oral cromoglycic acid with placebo.[1]

The brief summary says the study is evaluating the effect of oral disodium cromoglycate on fatigue in patients with multiple sclerosis.[1]

The main outcomes are the Modified Fatigue Impact Scale (MFIS) at the end of treatment compared with baseline, the Fatigue Severity Scale (FSS), and the PROMIS-SF-Fatigue measure for fatigue in multiple sclerosis.[1]

ALS study

The second trial, 2025-520688-42-00, is titled “Phase IIB Study of PHENOGENE-1A (Cromolyn) as an Adjuvant Therapy in Mild to Moderate ALS.”[2]

This study includes 155 participants and compares PHENOGENE-1A with a placebo capsule delivered by oral inhalation using a DPI.[2]

The study is designed to evaluate functional changes in people with mild to moderate ALS over a 24-week treatment period.[2]

The primary endpoint is the absolute change in ALSFRS-R total score from baseline to Week 24.[2]

What the endpoints mean

An endpoint is the main result a trial wants to measure.[1][2]

In the multiple sclerosis study, the endpoints focus on fatigue, which means how tired a person feels and how much that tiredness affects daily life.[1]

In the ALS study, the endpoint focuses on function, which means how well a person can carry out everyday activities.[2]

These measures help researchers see whether the study treatment may improve symptoms or daily functioning compared with placebo.[1][2]

Who can participate

The trial data show that the target groups are people with multiple sclerosis and people with mild to moderate ALS.[1][2]

The information provided does not list the full inclusion or exclusion criteria, so the exact participation rules are not shown here.[1][2]

How to read the results

Because both studies are placebo-controlled, the researchers can compare the active treatment with a non-active treatment group.[1][2]

This design helps show whether any change in fatigue or function is likely due to the study treatment rather than chance.[1][2]

The current data are focused on study design, target population, and planned outcomes, not on final results.[1][2]

Trial IDPhaseCondition studiedStatusEnrollment
2023-507541-29-00Phase 2Multiple sclerosisAuthorised120
2025-520688-42-00Phase 2Amyotrophic Lateral Sclerosis (ALS)Authorised155

FAQ

  • What conditions are being studied with Sodium Cromoglicate? The trials in this article study multiple sclerosis and amyotrophic lateral sclerosis (ALS). They look at whether Sodium Cromoglicate may help with symptoms or function in these groups.
  • Who may take part in these trials? One trial includes patients with multiple sclerosis, and the other includes people with mild to moderate ALS. Participation depends on the specific study criteria set by each trial.
  • What phase are the Sodium Cromoglicate trials? Both trials are phase 2 studies. Phase 2 trials usually look at early signs of benefit and continue to monitor safety.
  • What do the trials measure? The multiple sclerosis study measures fatigue using patient-reported scales. The ALS study measures change in the ALSFRS-R score, which checks daily function over time.
  • Are these studies comparing Sodium Cromoglicate with another treatment? Yes. Both trials include a placebo group, which is a non-active treatment used for comparison. This helps researchers see whether the study drug makes a real difference.

Sperimentazioni cliniche in corso su Sodium Cromoglicate

  • Studio del cromoglicato di sodio per via inalatoria come trattamento aggiuntivo in pazienti con Sclerosi Laterale Amiotrofica (SLA) da lieve a moderata

    In arruolamento

    1
    Malattie in studio:
    Farmaci in studio:
    Cechia Germania Polonia Spagna

  • Studio sull’efficacia e sicurezza del sodio cromoglicato nei pazienti con sclerosi multipla

    Arruolamento concluso

    1 1
    Farmaci in studio:
    Spagna

Glossario

  • Clinical trial: A research study in people that checks whether a treatment is safe, works, or both.
  • Phase 2: A study stage that looks for early signs that a treatment may help and continues to check safety.
  • Placebo: A treatment that does not contain the active study medicine. It is used as a comparison.
  • Multiple sclerosis: A long-term disease that affects the brain and spinal cord and can cause many different symptoms.
  • Amyotrophic lateral sclerosis (ALS): A disease that affects nerve cells controlling muscles and can lead to weakness over time.
  • Fatigue: A strong feeling of tiredness or low energy that does not improve much with rest.
  • Patient-reported outcome: Information about symptoms or daily life reported directly by the patient.
  • MFIS: Modified Fatigue Impact Scale, a questionnaire that measures how fatigue affects daily life.
  • FSS: Fatigue Severity Scale, a tool used to rate how severe fatigue is.
  • PROMIS-SF-Fatigue: A short questionnaire used to measure fatigue reported by the patient.
  • ALSFRS-R: Amyotrophic Lateral Sclerosis Functional Rating Scale-Revised, a score that measures function in people with ALS.

Riferimenti

  1. https://clinicaltrials.gov/study/2023-507541-29-00
  2. https://clinicaltrials.gov/study/2025-520688-42-00