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

NCT ID: NCT06223074

Last Updated: 2025-04-03

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Clinical Phase: PHASE2
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-01-09
• Study Completion Date: 2026-07-05

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.

Conditions

Multiple Sclerosis Relapsing Remitting; Treatment

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Standard Intravenous Methylprednisolone treatment in relapsing-remittent multiple sclerosis

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.

Group Type: ACTIVE_COMPARATOR

IV Methylprednisolone administration

Intervention Type: OTHER

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

Intranasal Methylprednisolone administration in relapsing-remittent multiple sclerosis

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

Group Type: EXPERIMENTAL

Nasal Methylprednisolone (MT)

Intervention Type: 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

Interventions

IV Methylprednisolone administration

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

Intervention Type: OTHER

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

Intervention Type: DRUG

Other Intervention Names

ST; Nasal MT

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Instituto Nacional de Neurología y Neurocirugía

UNKNOWN

Sponsor Role: collaborator

Universidad Nacional Autonoma de Mexico

OTHER

Sponsor Role: lead

Responsible Party

Edda Sciutto Conde

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Instituto Nacional de Neurología y Neurocirugía

Mexico City, , Mexico

Countries

Mexico

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

BD2012-34CEC

Identifier Type: -

Identifier Source: org_study_id