Status:
COMPLETED
Cognition and MRI Markers in MS Patients With Aubagio® Treatment
Lead Sponsor:
University Hospital, Bordeaux
Collaborating Sponsors:
Genzyme, a Sanofi Company
Conditions:
Multiple Sclerosis, Relapsing-Remitting
Eligibility:
All Genders
18-60 years
Phase:
NA
Brief Summary
Cognitive impairment is nowadays more and more recognized as an important feature of the multiple sclerosis (MS) disease which contributes largely to disability. Cognitive assessment using classical n...
Eligibility Criteria
Inclusion
- PATIENTS
- Male or female
- Age 18-60 years
- RRMS diagnosis according to McDonald criteria (Polman et al., 2005);
- Treated with Aubagio® (Indication for first line therapy)
- Native French speaking
- Being affiliated to health insurance
- Having signed an informed consent (at the latest on the day of inclusion and before any examination required by research)
- HEALTHY CONTROLS
- Male or Female,
- Age 18-60 years
- Willing to participate and to sign informed consent.
- Being affiliated to health insurance
- Having signed an informed consent (at the latest on the day of inclusion and before any examination required by research)
Exclusion
- PATIENTS
- History of neurological disease and/or other neurological diseases,
- Psychiatric comorbidity including severe depression according to DSM-IV,
- Alcohol or other addiction to toxic,
- Disabling visual or motor problems preventing participation to neuropsychological assessments,
- Acquisition disorders : Dyslexia, Dysphasia, Dyscalculia and dyspraxia,
- Dosage change, stop or start of hypnotic or anxiolytic or antidepressive treatment less than 30 days
- Relapse since less than one month,
- Steroid treatment less than one month (be taken orally or by infusion) at the dosage of 500mg daily,
- Prior neuropsychological testing with the same tests less than 6 months
- Contra-indication to MRI (pacemakers, aneurysm clips, artificial heart valves, ear implants, metal fragments or foreign objects in the eyes, skin or body, claustrophobia) or refusing MRI
- Illiteracy, is unable to count or to read
- Pregnant or breastfeeding women
- Patient concerned by articles L 1121-5 to L 1121-8 (persons deprived of their liberty by a judicial or administrative decision, minors, persons of legal age who are the object of a legal protection measure or unable to express their consent)
- HEALTHY CONTROLS
- History of neurological disease and/or neurological diseases
- Psychiatric comorbidity including severe depression according to DSM-IV;
- Alcohol or other toxic addiction;
- Known cognitive complaint or neuropsychological affection
- Hypnotic or anxiolytic or antidepressive treatment,
- Prior neuropsychological testing with the same tests less than 6 months
- Acquisition disorders: Dyslexia, Dysphasia, Dyscalculia and dyspraxia,
- Steroid treatment less than one month (be taken orally or by infusion) at the dosage of 500mg daily,
- Contra-indication to MRI (pacemakers, aneurysm clips, artificial heart valves, ear implants, metal fragments or foreign objects in the eyes, skin or body, claustrophobia) or refusing MRI
- Illiteracy, is unable to count or to read
- Pregnant or breastfeeding women
- Person concerned by articles L 1121-5 to L 1121-8 (persons deprived of their liberty by a judicial or administrative decision, minors, persons of legal age who are the object of a legal protection measure or unable to express their consent)
Key Trial Info
Start Date :
May 21 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 23 2023
Estimated Enrollment :
75 Patients enrolled
Trial Details
Trial ID
NCT03768648
Start Date
May 21 2019
End Date
February 23 2023
Last Update
March 8 2023
Active Locations (1)
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1
CHU de Bordeaux - Service de neurologie
Bordeaux, France