In short
Clinical trials are investigating Sodium Cromoglicate in people with multiple sclerosis and amyotrophic lateral sclerosis (ALS). These studies are looking at whether it can improve symptoms and function, and they are also measuring safety and treatment effects. Both trials are in Phase 2 and include adults with specific disease stages.
Key points
- Clinical trials of Sodium Cromoglicate are being done in two different diseases: multiple sclerosis and amyotrophic lateral sclerosis (ALS). Both studies are Phase 2 and are authorised. One trial looks at fatigue in people with multiple sclerosis, while the other looks at function in people with mild to moderate ALS. The trials use patient-reported scales and function scores to measure change over time. Planned enrollment is 120 people in the multiple sclerosis study and 155 people in the ALS study.
Clinical trials overview
The available trial data show two interventional studies of Sodium Cromoglicate, both in Phase 2 and both marked Authorised. One study is in people with multiple sclerosis, and the other is in people with amyotrophic lateral sclerosis (ALS).
These trials are not broad drug monographs; they are research studies that ask whether Sodium Cromoglicate may help with specific symptoms or function in selected patient groups.
Multiple sclerosis trial
The first trial is titled “EFFICACY AND SAFETY OF CROMOGLYCATE AS A NEW SYMPTOMATIC TREATMENT IN PATIENTS WITH MULTIPLE SCLEROSIS.” It is studying people with multiple sclerosis and is designed to evaluate whether oral cromoglycate can reduce fatigue compared with placebo.
This study plans to enroll 120 participants and is listed as Phase 2. The brief summary says it is evaluating oral disodium cromoglycate versus placebo for fatigue in patients with multiple sclerosis.
The main outcome measures are Modified Fatigue Impact Scale (MFIS), Fatigue Severity Scale (FSS), and PROMIS-SF-Fatigue. These are patient-reported tools, which means people answer questions about how tired they feel and how fatigue affects daily life.
ALS trial
The second trial is titled “Phase IIB Study of PHENOGENE-1A (Cromolyn) as an Adjuvant Therapy in Mild to Moderate ALS.” It is studying people with mild to moderate ALS and is looking at whether PHENOGENE-1A (cromolyn) can improve functional change over 24 weeks.
This study plans to enroll 155 participants and is also Phase 2. The brief summary says it is evaluating functional changes in subjects with mild to moderate stage ALS using the ALSFRS-R score over a 24-week treatment period.
The main outcome is the absolute change in ALSFRS-R total score from baseline to Week 24. Baseline means the starting point before treatment begins, and Week 24 means the end of the planned study period.
Outcomes and measures
In the multiple sclerosis study, the focus is fatigue, which is a strong and ongoing feeling of tiredness that can affect daily activities. The study uses three tools to measure this symptom: MFIS, FSS, and PROMIS-SF-Fatigue.
In the ALS study, the focus is function, measured by ALSFRS-R. This score is used to track how ALS affects daily abilities over time.
Both studies compare a study treatment with placebo, which is an inactive look-alike treatment used to make the comparison fair.
Who the trials include
The multiple sclerosis trial is for patients with multiple sclerosis. The ALS trial is for people with ALS, specifically those with mild to moderate disease.
These studies are not for the general public; they are for patients who match the trial rules set by the researchers. The source data do not provide the full eligibility rules, so the exact age limits, test results, and other entry rules are not listed here.
Trial status and size
Both trials are listed as Authorised, which means they have been approved to proceed in the source record. The multiple sclerosis study plans to enroll 120 people, while the ALS study plans to enroll 155 people.
These sample sizes suggest that the studies are designed to look for early signs of benefit and to gather more information about how Sodium Cromoglicate performs in these patient groups.