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

Phase 1

• Conditions: Multiple sclerosis; MedDRA version: 20.1Level: LLTClassification code: 10039720Term: Sclerosis multiple Class: 10029205; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: CTIS2023-507541-29-00
• Lead Sponsor: Fundacion Para La Investigacion Biomedica Del Hospital Clinico San Carlos

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-08-30
• Last Update Posted: 22 July 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

Age between 18 and 60 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).

Exclusion Criteria

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified