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

Phase 2

• Conditions: Multiple Sclerosis Relapsing Remitting; Treatment
• Interventions: Drug: Nasal Methylprednisolone (MT); Other: IV Methylprednisolone administration

• Registration Number: NCT06223074
• Lead Sponsor: Universidad Nacional Autonoma de Mexico

Brief Summary

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

Detailed Description

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 Timeline

• Study Start: 2023-01-09
• Study First Submitted: 2023-04-25
• Study First Submitted QC: 2024-01-15
• Study First Posted: 2024-01-25
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-31
• Last Update Posted: 2025-04-03
• Primary Completion: 2026-02-25
• Study Completion: 2026-07-05

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 80

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intranasal Methylprednisolone administration in relapsing-remittent multiple sclerosis	Nasal Methylprednisolone (MT)	Nasal Methylprednisolone Administration For this group, 40 randomly enrolled patients aged 18-65 years with relapsing-remitting multiple sclerosis that assist to the hospital and confirmed with a relapse, will be treated with intranasal methylprednisolone administration (1000 mg once a day for 3 days for moderate relapses or 5 days for severe ones) using a Mucosal Atomization Device (MAD Nasal). A written informed consent will be obtained from each participant or a legal representative whenever the participant could not provide consent
Standard Intravenous Methylprednisolone treatment in relapsing-remittent multiple sclerosis	IV Methylprednisolone administration	Intravenous methylprednisolone is the standard treatment for a multiple sclerosis relapse. Thus, 40 randomly enrolled patients aged 18-65 years with relapsing-remitting multiple sclerosis that assist to the hospital and confirmed with a relapse, will be treated with intravenous methylprednisolone, 1000 mg, once a day for 3 days for moderate relapses or 5 days for severe ones. A written informed consent will be obtained from each participant or a legal representative whenever the participant could not provide consent.

Primary Outcome Measures

Name	Time	Method
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

Secondary Outcome Measures

Name	Time	Method
Concentration of inflammatory cytokines and chemokines in peripheral blood before, during, and after treatment	Days 0, 5 and 30 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

Trial Locations

Locations (1)

Instituto Nacional de Neurología y Neurocirugía; 🇲🇽 Mexico City, Mexico