A Phase 2 interventional study of IV Methylprednisolone administration and Nasal Methylprednisolone (MT) in Multiple Sclerosis Relapsing Remitting and Treatment, sponsored by Universidad Nacional Autonoma de Mexico. Enrolling by invitation at 1 site in Mexico. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2025-04-03.
Sponsored by Universidad Nacional Autonoma de Mexico · Phase 2, Interventional, and Treatment
This Clinical Trial evaluates the nasal administration of Methylprednisolone as a treatment strategy for Acute Relapses in Multiple Sclerosis
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.
618 studies on the registry are indexed under Multiple Sclerosis, Relapsing-Remitting; 82 are open to participants now.
This study's planned enrollment of 80 is above the median of 66 across 437 interventional studies indexed under Multiple Sclerosis, Relapsing-Remitting.
Browse Multiple Sclerosis, Relapsing-Remitting studies →Universidad Nacional Autonoma de Mexico is the lead sponsor of 28 studies on the registry; 9 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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)
Group 1 will receive 1g methylprednisolone IV for 3 or 5 days, according to the severity of the relapse
Also known as: ST
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
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
Time frame: Days 0 and 30 after treatment
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
Time frame: Days 0, 5 and 30 after treatment
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
Time frame: 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
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
Time frame: Days 0 and 30 after treatment
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
Time frame: Day 30 after treatment
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Yes — Information exchange for research purposes
Supporting information: Study protocol, Clinical study report
Time frame: Upon study completion, by request
Started Jan 2023 (actual). Primary completion is estimated for Feb 2026, 37 months after the start.
Of 25 phase 2 interventional studies under Multiple Sclerosis, Relapsing-Remitting, half reached primary completion within 41 months of starting (the median), counting those still running; a quarter within 22 and three quarters within 67. This study's planned 37 months is close to that.
How these figures are worked out, and which studies are left out of them.
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Multiple Sclerosis, Relapsing-Remitting →
Universidad Nacional Autonoma de Mexico