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NCT06223074Enrolling by invitationPhase 2

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

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

Source: ClinicalTrials.gov · Last updated 3 Apr 2025 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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

Status (registry)
Enrolling by invitation
Phase (registry)
Phase 2
Study type
Interventional
Enrollment
80 (estimated)
First submitted
25 Apr 2023
Start date
9 Jan 2023
Primary completion date
25 Feb 2026
Lead sponsor
Universidad Nacional Autonoma de Mexico
NCT number
NCT06223074

What you commit to

  • Study type: Interventional · Phase 2
  • Planned participants: 80
  • From 9 Jan 2023 to the primary completion date, 25 Feb 2026
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Intake of anti-inflammatory steroids in the last 3 days.

Other illness

  • Patients with active bacterial, viral or fungal infections or undergoing treatment.
  • Patients with hypertension.
  • Patients with diabetes mellitus.
  • Diagnosis of systemic diseases such as: cardiovascular, pulmonary, hepatic, endocrine, gastrointestinal, etc.
  • 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 with allergic rhinitis.
  • Patients with upper respiratory tract infections.
  • History of nasal surgery.

Lab values

  • Patients with suspected or confirmed pregnancy by means of serum or urinary laboratory tests.

Other

  • Patients with hypo or hyperthyroidism.
  • Patients with glaucoma.
  • Patients with neoplasms.
  • Breastfeeding patients.
  • Patients diagnosed with active sinusitis.
  • deviated septum

Who the study is looking for

  • 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

Age in the registry: 18 years to 65 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Instituto Nacional de Neurologia y Neurocirugia
Coordinator of this site? Confirm its status
Mexico CityMexicoUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.