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A phase IV, unicentric, open label clinical trial to evaluate the default mode network in multiple sclerosis patients on Cladribine treatment

Phase 1
Conditions
Multiple Sclerosis
MedDRA version: 20.1Level: PTClassification code: 10028245Term: Multiple sclerosis Class: 100000004852
Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Registration Number
CTIS2023-504577-21-00
Lead Sponsor
María Luisa Martínez Ginés
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
ot Recruiting
Sex
All
Target Recruitment
20
Inclusion Criteria

MS diagnostic following McDonald 2010 diagnosis criteria., Age between 30 and 55 years old., MS patients that started treatment with cladribine tablets in the last month., Consent form signature

Exclusion Criteria

Dementia diagnosis, following Spanish Neurological Society criteria., Mayor psychiatric illness., Physical or intellectual limitations to successfully perform neuropsychological evaluation., Any other circumstance that may interfere with functional magnetic resonance session, Abnormal renal function previous to MRI session., Pregnant or breastfeeding females or males and females of childbearing potential not willing to use a medically acceptable contraceptive method from enrolment until six months after the end of the treatment

Study & Design

Study Type
Interventional clinical trial of medicinal product
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod
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