Status:
UNKNOWN
Neurocognitive Changes in Patients With Remitting Relapsing Multiple Sclerosis Treated With Natalizumab
Lead Sponsor:
Cantonal Hospital of St. Gallen
Collaborating Sponsors:
Biogen
Conditions:
Multiple Sclerosis
Cognitive Impairment
Eligibility:
All Genders
18-55 years
Brief Summary
Cognitive impairment is seen in about half of patients with relapsing remitting MS. Our knowledge about long term development of cognitive performance under natalizumab therapy is limited. We want to ...
Detailed Description
Impaired cognitive function may represent damage to brain regions that are not involved in physical functions, hence may not be detected during routine neurological assessment. Despite the high preval...
Eligibility Criteria
Inclusion
- Patients between 18 and 55 years at presentation
- Diagnosis of relapsing-remitting MS according to revised McDonald criteria 2005
- Patients treated with ntz
- EDSS under 5.5
Exclusion
- Brain pathology other than MS
- Known history of head trauma
- Pure spinal manifestation of demyelization
- Neuromyelitis optica
- Primary and secondary progressive MS
- Benzodiazepine intake within the last three months
- Relapse within the last three months
- Steroid intake within the last three months
- History of severe depressive disorder and/or suicidality, seizure, drug or alcohol abuse
- No informed consent
- Insufficient knowledge of German
Key Trial Info
Start Date :
January 1 2011
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
June 1 2014
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT01250678
Start Date
January 1 2011
End Date
June 1 2014
Last Update
December 1 2010
Active Locations (1)
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1
Cantonal Hospital of Saint Gallen
Sankt Gallen, Switzerland, 9007