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Corticosteroid Effects on Asymptomatic Gadolinium-enhancing Lesions in Multiple Sclerosis

NCT04979650 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 102

Last updated 2025-07-15

No results posted yet for this study

Summary

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.

Conditions

  • Multiple Sclerosis, Relapsing-Remitting
  • Magnetic Resonance Imaging
  • Methylprednisolone

Interventions

DRUG

Methylprednisolone succinate

1 gram of methylprednisolone succinate within 500 ccs of normal saline

DRUG

Normal saline

500 g of normal saline without methylprednisolone succinate

Sponsors & Collaborators

  • Mazandaran University of Medical Sciences

    lead OTHER

Principal Investigators

  • Seyed Mohammad Baghbanian, Dr. · Mazandaran University of Medical Sciences

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-05-22
Primary Completion
2023-12-28
Completion
2023-12-29

Countries

  • Iran

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04979650 on ClinicalTrials.gov