Clinical trial NCT06223074: Improving the Treatment of Acute Relapses in Multiple Sclerosis Through Intranasal Methylprednisolone Administration
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
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: PHASE2
Conditions: Multiple Sclerosis Relapsing Remitting
Treatment
Keywords: methylprednisolone
intranasal administration
Multiple Sclerosis Relapsing Remitting
Lead sponsor: Universidad Nacional Autonoma de Mexico
Sponsor class: OTHER
Collaborators: name: Instituto Nacional de Neurología y Neurocirugía
First posted: 2024-01-25
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A prospective, comparative, randomized, controlled study in adult patients with confirmed Relapsing-Remitting Multiple Sclerosis that assits to the hospital with an acute relapse.
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Patients' score on the Expanded Disability Status Scale (EDSS) before and after treatment to assess clinical efficacy of treatments
timeFrame: Days 0 and 30 after treatment
Secondary outcomes:
measure: Concentration of inflammatory cytokines and chemokines in peripheral blood before, during, and after treatment
timeFrame: Days 0, 5 and 30 after treatment
Other outcomes:
measure: Levels of lymphocyte subsets in peripheral blood before, during, and after treatment
timeFrame: Days 0, 5 and 30 after treatment
measure: Shannon and Chao1 indexes in feces samples to determine diversity and composition of intestinal microbiota in patients before and after treatment
timeFrame: Days 0 and 30 after treatment
measure: Number of patients with adverse effects related to the methylprednisolone intranasal treatment as assessed by a questionnaire
timeFrame: Day 30 after treatment
Locations:
city: Mexico City
country: Mexico
facility: Instituto Nacional de Neurología y Neurocirugía
Study officials:
References: