G35
Conditions
Interventions
Group 1: Relatives (children, siblings) of patients diagnosed with multiple sclerosis are recruited. At the time of recruitment, the study participants fill out a standardized questionnaire and a bloo
Sponsors
Klinikum Rechts der Isar
Eligibility
Sex/Gender
All
Age
18 Years to 50 Years
Inclusion criteria
Inclusion criteria: Male and female patients between the age of 18 and 50 years with direct relatives (siblings, children) diagnosed with MS Having given written informed consent prior to undertaking any study-related procedures. Covered by a health insurance system where applicable, and/or in compliance with the recommendations of the national laws in force relating to biomedical research.
Exclusion criteria
Exclusion criteria: Patients who have met all the above inclusion criteria will be screened for the following exclusion criteria: Under any administrative or legal supervision or unable to give informed consent. Conditions/situations such as: • Persons with conditions/concomitant diseases making them non-evaluable for the primary endpoint (e.g. pre-existing neurological disease, systemic autoimmune diseases) • Persons of a history of MS or of diseases with an increased MS risk (i.e. clinically isolated syndrome, isolated demyelinating even (e.g. optic neuritis, myelitis) • A requirement for concomitant treatment that could bias primary evaluation • An impossibility to meet specific protocol requirements (e.g., need for hospitalization, not able to read and understand the protocol) • A health condition that does not allow to perform an MRI or imposes a health risk to the participant when performing an MRI • The patient is the Investigator or a sub investigator, research assistant, pharmacist, study coordinator, other staff or relative there of directly involved in the conduct of the protocol • Is uncooperative or has any condition that could make the patient potentially non-compliant to the study procedures • Pregnant or breast-feeding women
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Prognostic value of the disease-risk stratification model for individuals at high risk to develop MS or radiologically isolated syndrome over a period of two years with possible extension to five years | — |
Secondary
| Measure | Time frame |
|---|---|
| Association of the disease-risk stratification model with clinical, MRI and other outcomes after 24 and 60 months | — |
Countries
Germany, Italy, Norway, Spain, Sweden
Contacts
Public ContactBernhard Hemmer
Klinikum Rechts der Isar
Outcome results
None listed