EFFICACY AND SAFETY OF CROMOGLYCATE AS A NEW SYMPTOMATIC TREATMENT IN PATIENTS WITH MULTIPLE SCLEROSIS
Key facts
- Where
- Fuenlabrada és Madrid, SpanyolországSee the 2 sites
- Phase
- 2. fázis
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 64 years old?
Where in Spanyolország
- Hospital Universitario de FuenlabradaFuenlabrada, SpanyolországNo longer taking part
- Hospital Clínico San CarlosMadrid, SpanyolországNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Fundacion Para La Investigacion Biomedica Del Hospital Clinico San Carlos
- Trial code
- EU 2023-507541-29-00
- Record updated
- 2026. október 19.
- Original description
To evaluate the efficacy on fatigue of treatment with oral disodium cromoglycate (200-400 mg) versus placebo in patients with mutiple sclerosis.Read full original descriptionShow less
To evaluate the efficacy on fatigue of treatment with oral disodium cromoglycate (200-400 mg) versus placebo in patients with mutiple sclerosis.
Inclusion: 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).
Exclusion: Concomitant pathologies of the CNS or diseases that, in the opinion of the investigator, may alter the control of micturition; 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; 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; 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.