Improving the Treatment of Acute Relapses in Multiple Sclerosis Through Intranasal Methylprednisolone Administration

Launched by UNIVERSIDAD NACIONAL AUTONOMA DE MEXICO · Jan 15, 2024

Keywords

ClinConnect Summary

This trial is testing whether giving methylprednisolone as a nasal spray works as well as the standard IV (through the vein) steroid treatment for an acute relapse of relapsing-remitting multiple sclerosis (RRMS). It’s a randomized, double-blind study in adults, planned to enroll about 80 people split into two groups of 40. One group gets the usual IV methylprednisolone (1000 mg once daily for 3–5 days, depending on relapse severity) and the other group receives the same total dose given intranasally. The main goal is to see if the nasal method is not worse than the IV method by looking at disability scores 30 days after treatment.

Who may be eligible: adults aged 18–65 with RRMS who are currently having a relapse, with relapse duration from 3 months up to 10 years since diagnosis, and a disability score (EDSS) between 1 and 6. Exclusions include active infections, certain medical conditions (like high blood pressure or diabetes), pregnancy or breastfeeding, nasal problems or a history of poor tolerance to steroids, and other major illnesses. If you participate, you’ll be randomly assigned to one of the two treatments, and neither you nor your care team will know which one you receive. You’ll have tests and safety questionnaires before and after treatment, and researchers will also collect data on inflammation markers and, for some outcomes, gut bacteria. The study is being conducted in Mexico City at a national neurology institute and led by the Universidad Nacional Autónoma de México; results are not yet available and are expected around 2026.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Age between 18 and 65 years.
• • Diagnosis of RRMS with an evolution from diagnosis of 3 months to 10 years.
• • Kurtzke Expanded Disability Status Scale (EDSS) from 1 to 6 (grade 6 includes patients with unilateral aid to ambulate)
• • No contraindication for the administration of MP.
• • Agree to participate in the study by means of a signed informed consent
• Exclusion Criteria:
• • Intake of anti-inflammatory steroids in the last 3 days.
• • Patients with active bacterial, viral or fungal infections or undergoing treatment.
• • Patients with hypertension.
• • Patients with diabetes mellitus.
• • Patients with hypo or hyperthyroidism.
• • Patients with glaucoma.
• • Patients with neoplasms.
• • Diagnosis of systemic diseases such as: cardiovascular, pulmonary, hepatic, endocrine, gastrointestinal, etc.
• • Patients with suspected or confirmed pregnancy by means of serum or urinary laboratory tests.
• • Breastfeeding patients.
• • Patients with a history of resistance to glucocorticoids.
• • Patients with a history of severe adverse reactions to glucocorticoids.
• • Patients with a history of hyposmia or anosmia.
• • Patients diagnosed with active sinusitis.
• • Patients with allergic rhinitis.
• • Patients with upper respiratory tract infections.
• • deviated septum
• • History of nasal surgery.