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
Phase: PHASE2
Conditions: Multiple Sclerosis Relapsing Remitting, Treatment
Sponsor: Universidad Nacional Autonoma de Mexico

 
 
 
National Autonomous University of Mexico 
Biomedical Research Institute 
 
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 
 
 
 
 
 
 
PROTOCOL SUMMARY 
 
 
 
 
 
 
 
 
 
ClinicalTrials.gov Unique Protocol ID: BD2012-34CEC 
Version 1.0  
January 8, 2024 
 

 
 
PROTOCOL SUMMARY 
Brief Project Title: Evaluation of the efficacy and safety of intranasal methylprednisolone 
for the treatment of relapses in relapsing-remitting multiple sclerosis patients. 
 
STRUCTURED SUMMARY 
Introduction. Multiple Sclerosis (MS) is an autoimmune, inflammatory, demyelinating, and 
neurodegenerative disease of the central nervous system (CNS) that affects approximately 2.5 
million people worldwide and is the most important cause of non-traumatic neurological disability 
in young adults. In Mexico, the prevalence of MS has increased from 5 to 13 cases per 100,000 
inhabitants. MS requires acute treatment when relapse symptoms occur, otherwise, the patient 
has a very high risk of remaining with some disability, and even accumulating them. Among the 
current specific treatments for these relapses is intravenous (IV) methylprednisolone (MP), 
which is the standard treatment. In this work, we propose the intranasal (IN) route as an 
alternative to IV administration of MP to treat relapses in patients with relapsing-remitting 
multiple sclerosis (RRMS). 
Problem Statement. MS requires acute treatment when symptoms or relapses occur. Our 
working group has shown that the IN-administration route is more effective for the delivery of 
glucocorticoids to the CNS, and a better treatment to control neuroinflammation in different 
neuropathologies in preclinical trials. This suggests that IN administration of methylprednisolone 
could be at least as effective as IV administration in treating neuroinflammation in patients with 
MS. Here we propose the study of the administration of methylprednisolone by the IN versus the 
IV route to evaluate its effect in patients with RRMS. 
Purpose. To evaluate the efficacy, tolerability, and safety of methylprednisolone administered 
intranasally compared with intravenously in the recovery of patients with RRMS relapses. 
Hypothesis. Intranasal administration of 1 g of methylprednisolone is at least as effective and 
safe as the same dose administered intravenously in the recovery and reversal of neurological 
symptoms caused by relapses in patients with RRMS. 
Methodology. This is a prospective, comparative, double-blind, randomized, placebo-
controlled study, in accordance with the principles established by the Declaration of Helsinki, 
including informed consent. Patients from the Instituto Nacional de Neurología y Neurocirugía 
with a diagnosis of RRMS who are experiencing a relapse will be included. 
The recruited patients will be organized into two paired groups of 40 patients. Group 1 will 
receive 1g methylprednisolone IV and group 2 will receive 1g methylprednisolone IN. Clinical 
symptoms will be measured with EDSS and quality of life with the Barthel scale; The results of 
the serum concentration of MP and inflammatory markers will be collected. Adverse effects in 
each group will also be identified and quantified. 
Keywords: Relapsing-remitting multiple sclerosis, Methylprednisolone, Intranasal treatment.