A preliminary, multicenter study on the relationship between cortical damage and blood brain barrier damage in Multiple Sclerosis patients with high cortical disease activity,

Phase 1

• Conditions: Multiple Sclerosis; MedDRA version: 20.1Level: LLTClassification code 10039720Term: Sclerosis multipleSystem Organ Class: 100000004852; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: EUCTR2015-001202-34-IT
• Lead Sponsor: AZIENDA OSPEDALIERA UNIVERSITARIA INTEGRATA VERONA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-06-08
• Last Update Posted: 17 August 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 18

Inclusion Criteria

- Sex: Female and Male
- Age: = 18 years old
- Diagnosis of Multiple Sclerosis according to McDonald criteria, 2010 rev.
- EDSS 0-5.5
- Cerebral MRI with Gadolinium within two weeks the PET scanning
- High cortical disease activity (presence of at least 10 cortical lesions and/or epilepsy/seizures not secondary to non-MS pathology) and/or severe mnestic or executive impairment in neuropsychological tests.
- informed consent
- for [18F]-NaF-PET study, a sub-group of patients who presented seizures in the past 2 months will be chosen

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 18
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 0

Exclusion Criteria

- Co-occurring of other illness that can alter PET imaging (neoplasms, infectious disease, etc)
- previous brain surgery
- pregnancy (for women in reproductive age, a b-HCG test will be performed) or breast feeding
- allergy or intolerance to one or more of the drugs employed in this study

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified