NCT Number: NCT02523703
Excitotoxicity Markers and the Clinical-radiological Progression After a Demyelinating Event: a Prospective Pilot Study
Multiple sclerosis (MS) is an inflammatory disease of the central nervous system, beginning most often in subjects aged 20-40 years. In France, thanks to recent studies reported during general states of MS in 2006, the prevalence is estimated at 65.5 / 100,000 population (96.3 / 100,000 women and 41.9 / 100,000 men) and incidence at 7.91 per 100,000. In Lower Normandy, the incidence of MS is estimated to 4.45 / 100,000 inhabitants or 60 new cases per year.
The primary objective of this pilot study is to assess the levels of glutamate and aspartate (excitotoxicity markers) and their repercussions on the clinical and radiological outcome in 40 patients experiencing an event demyelinating central nervous system.
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Notify MeKey information
Conditions
Age range
18 year–60 year
Sex eligibility
All sexes
Study type
Interventional
Phase
Not applicable
Who can participate
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
- Man or woman between 18 and 60 years old.
- Patient with one or more type of inflammatory events of Central system suggestive of demyelinating disease (multiple sclerosis, neuromyelitis optical Devic extensive myelitis)
- No treatment with corticosteroids for less than 1 month
- Need for a lumbar puncture performed in the etiologic
- Need a brain MRI performed within the etiologic
- Patient who signed informed consent
Exclusion criteria
- Secondary progressive MS
- Any cons-indication for lumbar puncture
- Any contra-indication to MRI
- Minor patient or patient major under guardianship
Treatment and study plan
Primary outcomes
-
glutamate concentration (in nM)
Time frame: baseline
comparison between MS patients and controls
Sponsors and collaborators
Lead sponsor
University Hospital, Caen
Other
Registry information
Acronym: EXCEED
Important dates
- Study start
- 2007
- Primary completion
- 2012
- Study completion
- 2015
- First posted
- Aug 14, 2015
- Registry last updated
- Sep 2, 2020
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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