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NCT04979650CompletedPhase 2

Corticosteroid Effects on Asymptomatic Gadolinium-enhancing Lesions in Multiple Sclerosis

Corticosteroid Pulse Therapy Effects on MRI Asymptomatic Gadolinium-enhancing Lesions Conversion to a Non-enhancing Black Hole With or Without Treatment in MS Clinic of Booalisina Hospital Sari 2021-2023

Source: ClinicalTrials.gov · Last updated 15 Jul 2025

Brief summary (registry, in English)

to determine the rate of asymptomatic gadolinium-enhancing lesions conversion to the non-enhancing black hole (neBHs) with or without corticosteroid pulse therapy in patients with RRMS, and to analyze if treatment of asymptomatic gadolinium enhancement lesions has any effect on the expanded disability status scale. The study is performed in the MS clinic of Bu Ali Sina Hospital in Sari and Mazandaran University of Medical Sciences. 104 recurrent MS patients are admitted based on the admission criteria. They are divided into two groups of intervention and control based on a simple randomization block. The intervention group received 1 gram of methylprednisolone in 500 ccs of normal saline for 5 days and the control group received only 500 ccs of serum. After 6 months, a new MRI is taken from the patients and the possibility of asymptomatic active plaque conversion with or without intervention is compared in the two groups, as well as the amount of EDSS in the two groups. They do not know whether the patient is in the control group or the intervention.

Status (registry)
Completed
Phase (registry)
Phase 2
Study type
Interventional
Enrollment
102 (actual)
First submitted
2 Jul 2021
Start date
22 May 2021
Primary completion date
28 Dec 2023
Lead sponsor
Mazandaran University of Medical Sciences
NCT number
NCT04979650

What you commit to

  • Study type: Interventional · Phase 2
  • Participants enrolled: 102
  • From 22 May 2021 to the primary completion date, 28 Dec 2023
  • 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

  • Pulse therapy 3 months ago,

Other illness

  • More than 6 months ago slowly progressive disease
  • Systemic infections, including fungal infection
  • Uncontrolled hypertension
  • With known hypersensitivity to the steroid preparation

Who the study is looking for

  • All patients with a diagnosis of RR-MS
  • with a baseline MRI scan with at least one asymptomatic CEL on contrast-enhanced T1-weighted images

Age in the registry: 18 years to 55 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
Mazandaran University of medical sciences
Coordinator of this site? Confirm its status
SariIranUnknown status

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