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

Methylprednisolone Clinical Trial

— IN-DXM-EMRR  

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT06223074
• Other study ID #: BD2012-34CEC
• Status: Enrolling by invitation
• Phase: Phase 2
• Start date: January 9, 2023
• Est. completion date: February 5, 2025

Study information

• Verified date: January 2024
• Source: Universidad Nacional Autonoma de Mexico
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 80
• Est. completion date: February 5, 2025
• Est. primary completion date: November 27, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Methylprednisolone
• Multiple Sclerosis
• Recurrence
• Sclerosis

Intervention

Other:
• IV Methylprednisolone administration
Group 1 will receive 1g methylprednisolone IV for 3 or 5 days, according to the severity of the relapse

Drug:
• 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

Locations

Country	Name	City	State
Mexico	Instituto Nacional de Neurología y Neurocirugía	Mexico City

Sponsors (2)

Lead Sponsor	Collaborator
Universidad Nacional Autonoma de Mexico	Instituto Nacional de Neurología y Neurocirugía

Country where clinical trial is conducted

Mexico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Levels of lymphocyte subsets in peripheral blood before, during, and after treatment	•Flow cytometry will be performed using blood samples taken from patients prior to treatment, on day 5 of treatment and 30 days after treatment	Days 0, 5 and 30 after treatment
Other	Shannon and Chao1 indexes in feces samples to determine diversity and composition of intestinal microbiota in patients before and after treatment	16S rRNA will be sequenced from isolated microbial DNA obtained from patient samples to determine global microbial composition prior to treatment and 30 days after treatment	Days 0 and 30 after treatment
Other	Number of patients with adverse effects related to the methylprednisolone intranasal treatment as assessed by a questionnaire	• The physician will assess possible adverse effects of the treatment using a questionnaire 30 days after treatment	Day 30 after treatment
Primary	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	Concentration of inflammatory cytokines and chemokines in peripheral blood before, during, and 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	Days 0, 5 and 30 after treatment