CAMINA
What it found
No result yet.
What was tested
Treatment tested
- Cromolyn
Placebo or sham
- Placebo
What it measured
Main measures
Modified Fatigue Impact Scale (MFIS) at the end-of-treatment visit (V4) with respect to baseline.
FatigueFatigue Severity Scale (FSS).
FatiguePatient-reported outcome measurement information system for fatigue in multiple sclerosis (PROMIS-SF-Fatigue).
FatigueQuality of life (reported by participants)
Other measures (39)
Actionable Bladder Symptom Screening Tool (ABSST).
Bladder, bowel and sexual functionUrinary incontinence questionnaire (ICIQ-SF).
Bladder, bowel and sexual functionSandvik incontinence severity test.
Bladder, bowel and sexual functionBladder Control Scale (BLCS).
Bladder, bowel and sexual functionInternational Prostate Symptom Scale (IPSS).
Questionnaire on the specific impact of urinary problems on quality of life (Qualiveen)
Bladder, bowel and sexual functionQuality of life (reported by participants)SF-36 quality of life questionnaires.
Quality of life (reported by participants)EQ-5D quality of life questionnaire.
Quality of life (reported by participants)Hospital Anxiety and Depression Scale (HADS).
Mood and sleepBeck Depression Inventory (BDI).
Mood and sleep
Who could take part
MS (type not specified) · 18 to 64
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: - 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.
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
To evaluate the efficacy on fatigue of treatment with oral disodium cromoglycate (200-400 mg) versus placebo in patients with mutiple sclerosis.
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History
Started
Oct 2024
Finished
Apr 2026
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