Multiple Sclerosis Relapsing Remitting, Treatment
Conditions
Keywords
methylprednisolone, intranasal administration, Multiple Sclerosis Relapsing Remitting
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.
Interventions
OTHERIV Methylprednisolone administration
Group 1 will receive 1g methylprednisolone IV for 3 or 5 days, according to the severity of the relapse
DRUGNasal 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
Sponsors
Instituto Nacional de Neurología y Neurocirugía
Universidad Nacional Autonoma de Mexico
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Other
| Measure | Time frame | Description |
|---|---|---|
| Levels of lymphocyte subsets in peripheral blood before, during, and after treatment | Days 0, 5 and 30 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 |
| 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 | 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 |
| Number of patients with adverse effects related to the methylprednisolone intranasal treatment as assessed by a questionnaire | Day 30 after treatment | • The physician will assess possible adverse effects of the treatment using a questionnaire 30 days after treatment |
Countries
Mexico
Outcome results
None listed