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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02523703
Other study ID # 06-063
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 10, 2007
Est. completion date February 23, 2015

Study information

Verified date August 2020
Source University Hospital, Caen
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Completed
Enrollment 36
Est. completion date February 23, 2015
Est. primary completion date February 15, 2012
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 60 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Biological:
glutamate and aspartate


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
University Hospital, Caen

Outcome

Type Measure Description Time frame Safety issue
Primary glutamate concentration (in nM) comparison between MS patients and controls baseline
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