EFFICACY AND SAFETY OF CROMOGLYCATE AS A NEW SYMPTOMATIC TREATMENT IN PATIENTS WITH MULTIPLE SCLEROSIS

Prior treatment

• Concomitant pathologies of the CNS or diseases that, in the opinion of the investigator, may alter the control of micturition.

Other illness

• 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.
• Change in disease-modifying therapy in the last 3 months.
• Inability to perform MRI (claustrophobia, pacemakers, metal implants) or known allergy to gadolinium.

Lab values

• Hypersensitivity to sodium cromoglycate or to any of the excipients (microcrytalline cellulose).
• 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.

Other

• Inability to understand or sign the informed consent.
• Patients with permanent urinary catheters.
• Change in symptomatic treatment of fatigue and/or urinary incontinence in the last 3 months.
• Pregnant or lactating women.

• 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).