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Towards the Improvement of the Treatment of Acute Relapses in Multiple Sclerosis: A Randomized Double-blind, Non-inferiority Controlled Trial Comparing Intranasal Versus Intravenous Methylprednisolone
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.
Age
18 - 65 years
Sex
ALL
Healthy Volunteers
No
Instituto Nacional de Neurología y Neurocirugía
Mexico City, Mexico
Start Date
January 9, 2023
Primary Completion Date
February 25, 2026
Completion Date
July 5, 2026
Last Updated
April 3, 2025
80
ESTIMATED participants
IV Methylprednisolone administration
OTHER
Nasal Methylprednisolone (MT)
DRUG
Lead Sponsor
Universidad Nacional Autonoma de Mexico
Collaborators
NCT06510764
NCT05292664
Data Source & Attribution
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