Table of contents
- Clinical trials overview
- Multiple sclerosis trial
- ALS trial
- Outcomes and measures
- Who the trials include
- Trial status and size
Clinical trials overview
The available trial data show two interventional studies of Sodium Cromoglicate, both in Phase 2 and both marked Authorised.[1][2] One study is in people with multiple sclerosis, and the other is in people with amyotrophic lateral sclerosis (ALS).[1][2]
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.[1][2]
Multiple sclerosis trial
The first trial is titled “EFFICACY AND SAFETY OF CROMOGLYCATE AS A NEW SYMPTOMATIC TREATMENT IN PATIENTS WITH MULTIPLE SCLEROSIS.”[1] It is studying people with multiple sclerosis and is designed to evaluate whether oral cromoglycate can reduce fatigue compared with placebo.[1]
This study plans to enroll 120 participants and is listed as Phase 2.[1] The brief summary says it is evaluating oral disodium cromoglycate versus placebo for fatigue in patients with multiple sclerosis.[1]
The main outcome measures are Modified Fatigue Impact Scale (MFIS), Fatigue Severity Scale (FSS), and PROMIS-SF-Fatigue.[1] These are patient-reported tools, which means people answer questions about how tired they feel and how fatigue affects daily life.[1]
ALS trial
The second trial is titled “Phase IIB Study of PHENOGENE-1A (Cromolyn) as an Adjuvant Therapy in Mild to Moderate ALS.”[2] It is studying people with mild to moderate ALS and is looking at whether PHENOGENE-1A (cromolyn) can improve functional change over 24 weeks.[2]
This study plans to enroll 155 participants and is also Phase 2.[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.[2]
The main outcome is the absolute change in ALSFRS-R total score from baseline to Week 24.[2] Baseline means the starting point before treatment begins, and Week 24 means the end of the planned study period.[2]
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.[1] The study uses three tools to measure this symptom: MFIS, FSS, and PROMIS-SF-Fatigue.[1]
In the ALS study, the focus is function, measured by ALSFRS-R.[2] This score is used to track how ALS affects daily abilities over time.[2]
Both studies compare a study treatment with placebo, which is an inactive look-alike treatment used to make the comparison fair.[1][2]
Who the trials include
The multiple sclerosis trial is for patients with multiple sclerosis.[1] The ALS trial is for people with ALS, specifically those with mild to moderate disease.[2]
These studies are not for the general public; they are for patients who match the trial rules set by the researchers.[1][2] 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.[1][2]
Trial status and size
Both trials are listed as Authorised, which means they have been approved to proceed in the source record.[1][2] The multiple sclerosis study plans to enroll 120 people, while the ALS study plans to enroll 155 people.[1][2]
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.[1][2]
