Search / Trial NCT06223074

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

Launched by UNIVERSIDAD NACIONAL AUTONOMA DE MEXICO · Jan 15, 2024

Trial Information

Current as of December 22, 2024

Enrolling by invitation

Keywords

Methylprednisolone Intranasal Administration Multiple Sclerosis Relapsing Remitting

ClinConnect Summary

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...

Gender

ALL

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.

About Universidad Nacional Autonoma De Mexico

The Universidad Nacional Autónoma de México (UNAM) is a prestigious academic institution renowned for its commitment to research and innovation in the field of health sciences. As a leading sponsor of clinical trials, UNAM leverages its extensive resources and expertise to advance medical knowledge and improve patient outcomes. The university fosters interdisciplinary collaboration among its faculties, promoting rigorous scientific methodologies and ethical standards in clinical research. Through its dedication to education and public health, UNAM plays a pivotal role in addressing pressing medical challenges and contributing to the development of effective therapeutic interventions.

Locations

Mexico City, , Mexico

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Discussion 0