Excitotoxicity Markers and the Clinical-radiological Progression After a Demyelinating Event: a Prospective Pilot Study

NCT ID: NCT02523703

Last Updated: 2020-09-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-09-10

Study Completion Date

2015-02-23

Brief Summary

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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.

Detailed Description

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Conditions

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Multiple Sclerosis

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Healthy Volunteers

Healthy Volunteers

Group Type OTHER

glutamate and aspartate

Intervention Type BIOLOGICAL

Multiple Sclerosis patient

Multiple Sclerosis patient

Group Type OTHER

glutamate and aspartate

Intervention Type BIOLOGICAL

Interventions

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glutamate and aspartate

Intervention Type BIOLOGICAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University Hospital, Caen

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Other Identifiers

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06-063

Identifier Type: -

Identifier Source: org_study_id

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