Corticosteroid Effects on Asymptomatic Gadolinium-enhancing Lesions in Multiple Sclerosis

• Status: Enrolling by invitation
• Trial end date: 2023-10-23
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Mazandaran University of Medical Sciences
• Treatments: Methylprednisolone; Methylprednisolone Acetate; Methylprednisolone Hemisuccinate; Prednisolone; Prednisolone acetate; Prednisolone hemisuccinate; Prednisolone phosphate

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• Pulse therapy 3 months ago,

• More than 6 months ago slowly progressive disease

• Systemic infections, including fungal infection

• Uncontrolled hypertension

• With known hypersensitivity to the steroid preparation