Corticosteroid Effects on Asymptomatic Gadolinium-enhancing Lesions in Multiple Sclerosis

NCT04979650 | Completed Phase 2 DMC

• 1 other identifier: 978445
• Study Type: interventional
• Target: 102
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Multiple sclerosis; Methylprednisolone Pulse therapy; Asymptomatic enhancing lesions; Chronic black hole

Outcome Measures

Primary Outcomes (2)

• Number of black hole

  NeBH (to non-enhancing black hole) was defined as an area of unequivocal low signal intensity compared with normal-appearing white matter that did not show contrast uptake and was concordant with a hyperintense lesion seen on T2-weighted imaging.They have also been defined as T1-hypointensities persisting for more than 6 months after their appearance

  After 6 months

• Expanded disability status scale

  The EDSS quantifies disability in eight functional systems: pyramidal, cerebellar, brainstem, sensory, bowel and bladder, visual, cerebral, and other. It ranges from 1.0 to 4.5 for people affected with MS who are fully ambulatory, and from 5.0 to 9.5 for people with MS with impaired ambulation. The maximum grade, 10.0, represents death due to MS

  After 6 months

Study Arms (2)

The intervention group

ACTIVE COMPARATOR

The intervention group will receive 1 gram of methylprednisolone succinate within 500 ccs of normal saline within 5 hours.

Drug: Methylprednisolone succinate; Drug: Normal saline

The control group

PLACEBO COMPARATOR

The control group will receive 500 g of normal saline without methylprednisolone succinate.

Drug: Methylprednisolone succinate; Drug: Normal saline

Interventions

Methylprednisolone succinate DRUG

1 gram of methylprednisolone succinate within 500 ccs of normal saline

Also known as: Active

The control group; The intervention group

Normal saline DRUG

500 g of normal saline without methylprednisolone succinate

Also known as: Placebo

The control group; The intervention group

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mazandaran University of Medical Sciences: lead

Study Sites (1)

Mazandaran University of medical sciences

Sari, Mazandaran, 4815838477, Iran

Location

MeSH Terms

Conditions

Multiple Sclerosis, Relapsing-Remitting; Multiple Sclerosis

Interventions

Methylprednisolone Hemisuccinate; Exercise; Saline Solution

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Methylprednisolone; Prednisolone; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Seyed Mohammad Baghbanian, Dr.

  Mazandaran University of Medical Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Seyed Mohammad Baghbanian

Study Record Dates

• First Submitted: July 2, 2021
• First Posted: July 28, 2021
• Study Start: May 22, 2021
• Primary Completion: December 28, 2023
• Study Completion: December 29, 2023
• Last Updated: July 15, 2025

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: The access period starts 6 months after the results are published.
• Access Criteria: It will be available only to researchers working in academic and scientific institutions.

Locations

IR (1)