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

Phase 2Enrolling By InvitationNCT06223074

Universidad Nacional Autonoma de Mexico80 enrolled

Overview

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

This is a prospective, comparative, randomized, double-blind study adhered to the principles established by the Helsinki Declaration, including informed consent. Patients with a diagnosis of Relapsing-Remitting Multiple Sclerosis (RRMS) from the National Institute of Neurology and Neurosurgery (INNN) that are coursing with acute recurrency will be included. The recruited patients will be organized into two paired groups of 40 patients each, of which group 1 will receive 1g IV methylprednisolone, and group 2 will receive the intranasal dose equivalent to 1g of IV methylprednisolone. Clinical symptoms will be measured with the Expanded Disability Status Scale (EDSS) and data will be complemented with results of clinical tests, general laboratories and serum concentration of MP and inflammatory markers. Adverse effects in each group will also be identified and quantified. Statistical analysis: descriptive, assumption of normality, bivariate comparison of means and multivariate, in addition to intention to treat.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Multiple Sclerosis Relapsing Remitting Treatment

Interventions

IV Methylprednisolone administrationOTHER

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

Nasal Methylprednisolone (MT)DRUG

Group 2 will receive the dose intranasal equivalent to 1g of methylprednisolone for 3 or 5 days according to the severity of the relapse

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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.

Locations (1)

Instituto Nacional de Neurología y Neurocirugía

Mexico City, Mexico

Outcomes

Primary Outcomes

Patients' score on the Expanded Disability Status Scale (EDSS) before and after treatment to assess clinical efficacy of treatments

* 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

Time frame: Days 0 and 30 after treatment

Secondary Outcomes

Concentration of inflammatory cytokines and chemokines in peripheral blood before, during, and after treatment

Enzyme-Linked Immunosorbent Assay (ELISA) to detect inflammatory molecules will be performed in plasma derived from blood samples taken from patients prior to treatment, on day 5 of treatment and 30 days after treatment

Time frame: Days 0, 5 and 30 after treatment

Data from ClinicalTrials.gov

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