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EFFICACY AND SAFETY OF CROMOGLYCATE AS A NEW SYMPTOMATIC TREATMENT IN PATIENTS WITH MULTIPLE SCLEROSIS
EU CTIS ID: 2023-507541-29-00
What this study is testing
To evaluate the efficacy on fatigue of treatment with oral disodium cromoglycate (200-400 mg) versus placebo in patients with mutiple sclerosis.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Age between 18 and 65 years.
- Diagnosis of multiple sclerosis according to the 2017 McDonald criteria, with more than 6 months of follow-up and clinically stable (without flare-ups or new lesions) in the last 6 months.
- EDSS between 1.0 and 6.5 points.
- Presence of moderate fatigue for at least 6 months (defined by a score on the MFIS scale ≥ 33 points) and urinary dysfunction (defined by 2 points or more on the ABSST Test).
You likely can't join if
- Inability to understand or sign the informed consent.
- Hypersensitivity to sodium cromoglycate or to any of the excipients (microcrytalline cellulose).
- Concomitant pathologies of the CNS or diseases that, in the opinion of the investigator, may alter the control of micturition.
- Patients with permanent urinary catheters.
- Severe renal or hepatic impairment, history of myocardial infarction, or other clinically significant medical problems that, in the opinion of the investigators, may expose the patient to undue risk or harm, or render the patient unable to complete the study.
- Abnormal results on baseline blood tests, defined as: serum alanine transaminase or aspartate transaminase levels greater than five times the upper limit of normal, serum creatinine level greater than 1.5 mg/dL, or estimated glomerular filtration rate less than 60 mL /min/1.73 m2.
See the full eligibility criteria
- Age between 18 and 65 years.
- Diagnosis of multiple sclerosis according to the 2017 McDonald criteria, with more than 6 months of follow-up and clinically stable (without flare-ups or new lesions) in the last 6 months.
- EDSS between 1.0 and 6.5 points.
- Presence of moderate fatigue for at least 6 months (defined by a score on the MFIS scale ≥ 33 points) and urinary dysfunction (defined by 2 points or more on the ABSST Test).
- Inability to understand or sign the informed consent.
- Hypersensitivity to sodium cromoglycate or to any of the excipients (microcrytalline cellulose).
- Concomitant pathologies of the CNS or diseases that, in the opinion of the investigator, may alter the control of micturition.
- Patients with permanent urinary catheters.
- Severe renal or hepatic impairment, history of myocardial infarction, or other clinically significant medical problems that, in the opinion of the investigators, may expose the patient to undue risk or harm, or render the patient unable to complete the study.
- Abnormal results on baseline blood tests, defined as: serum alanine transaminase or aspartate transaminase levels greater than five times the upper limit of normal, serum creatinine level greater than 1.5 mg/dL, or estimated glomerular filtration rate less than 60 mL /min/1.73 m2.
- Change in disease-modifying therapy in the last 3 months.
- Change in symptomatic treatment of fatigue and/or urinary incontinence in the last 3 months.
- Pregnant or lactating women.
- Inability to perform MRI (claustrophobia, pacemakers, metal implants) or known allergy to gadolinium.
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.