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

NCT06223074 | Enrolling By Invitation Phase 2 DMC

• 1 other identifier: BD2012-34CEC
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Multiple Sclerosis Relapsing Remitting; Treatment

Keywords

methylprednisolone; intranasal administration; Multiple Sclerosis Relapsing Remitting

Outcome Measures

Primary Outcomes (1)

• 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

  Days 0 and 30 after treatment

Secondary Outcomes (1)

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

  Days 0, 5 and 30 after treatment

Other Outcomes (3)

• Levels of lymphocyte subsets in peripheral blood before, during, and after treatment

  Days 0, 5 and 30 after treatment

• Shannon and Chao1 indexes in feces samples to determine diversity and composition of intestinal microbiota in patients before and after treatment

  Days 0 and 30 after treatment

• Number of patients with adverse effects related to the methylprednisolone intranasal treatment as assessed by a questionnaire

  Day 30 after treatment

Study Arms (2)

Standard Intravenous Methylprednisolone treatment in relapsing-remittent multiple sclerosis

ACTIVE COMPARATOR

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.

Other: IV Methylprednisolone administration

Intranasal Methylprednisolone administration in relapsing-remittent multiple sclerosis

EXPERIMENTAL

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

Drug: Nasal Methylprednisolone (MT)

Interventions

IV Methylprednisolone administration OTHER

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

Also known as: ST

Standard Intravenous Methylprednisolone treatment in relapsing-remittent multiple sclerosis

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

Also known as: Nasal MT

Intranasal Methylprednisolone administration in relapsing-remittent multiple sclerosis

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universidad Nacional Autonoma de Mexico: lead
• Instituto Nacional de Neurología y Neurocirugía: collaborator

Study Sites (1)

Instituto Nacional de Neurología y Neurocirugía

Mexico City, 14269, Mexico

Location

MeSH Terms

Conditions

Multiple Sclerosis, Relapsing-Remitting

Condition Hierarchy (Ancestors)

Multiple Sclerosis; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: A prospective, comparative, randomized, controlled study in adult patients with confirmed Relapsing-Remitting Multiple Sclerosis that assits to the hospital with an acute relapse.

Study Record Dates

• First Submitted: April 25, 2023
• First Posted: January 25, 2024
• Study Start: January 9, 2023
• Primary Completion: February 25, 2026
• Study Completion (Estimated): July 5, 2026
• Last Updated: April 3, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, CSR
• Time Frame: Upon study completion, by request

Locations

ME (1)