Running, not recruitingPhase 2MS (type not specified)2023-507541-29-00

What it found

Still running

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.

    Fatigue
  • Fatigue Severity Scale (FSS).

    Fatigue
  • Patient-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 function
  • Urinary incontinence questionnaire (ICIQ-SF).

    Bladder, bowel and sexual function
  • Sandvik incontinence severity test.

    Bladder, bowel and sexual function
  • Bladder Control Scale (BLCS).

    Bladder, bowel and sexual function
  • International 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 sleep
  • Beck 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

    1. Started

      Oct 2024

    2. Finished

      Apr 2026

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