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Clinical Trials in Mexico / NCT06223074
Enrolling by invitation Phase 2

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

NCT06223074 · tracked via the Priya Life Science Mexico tracker
Sponsor
Universidad Nacional Autonoma de Mexico
Phase
Phase 2
Started
2023-01-09
Last updated
2025-04-03

Condition(s) studied

Multiple Sclerosis Relapsing RemittingTreatment

Investigational drug(s) / intervention(s)

IV Methylprednisolone administrationNasal Methylprednisolone (MT)

IV Methylprednisolone administration: Group 1 will receive 1g methylprednisolone IV for 3 or 5 days, according to the severity of the relapse

Nasal Methylprednisolone (MT): Group 2 will receive the dose intranasal equivalent to 1g of methylprednisolone for 3 or 5 days according to the severity of the relapse

Study summary

This Clinical Trial evaluates the nasal administration of Methylprednisolone as a treatment strategy for Acute Relapses in Multiple Sclerosis

Eligibility

Sex
ALL
Min age
18 Years
Max age
65 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

  • Patients' score on the Expanded Disability Status Scale (EDSS) before and after treatment to assess clinical efficacy of treatments — Days 0 and 30 after treatment
    * The Expanded Disability Status Scale has a minimum score of 0, when the patient has no MS-related disability or abnormalities, and a maximum score of 10, when death is caused by MS. * Patients will be assessed with the EDSS prior to treatment and 30 days after the treatment ends

Trial sites (1)

FacilityCityRegionStatus
Instituto Nacional de Neurología y Neurocirugía Mexico City Mexico

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06223074 on ClinicalTrials.gov ↗ ← All trials in Mexico