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

Sponsor

University Hospital, Caen (Other)

Overall Status

Completed

CT.gov ID

NCT02523703

Collaborator

(none)

Enrollment

Arms

89.5

Actual Duration (Months)

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Multiple Sclerosis	Biological: glutamate and aspartate	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

36 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Basic Science

Actual Study Start Date :

Sep 10, 2007

Actual Primary Completion Date :

Feb 15, 2012

Actual Study Completion Date :

Feb 23, 2015

Arms and Interventions

Arm	Intervention/Treatment
Other: Healthy Volunteers Healthy Volunteers	Biological: glutamate and aspartate
Other: Multiple Sclerosis patient Multiple Sclerosis patient	Biological: glutamate and aspartate

Arm

Intervention/Treatment

Other: Healthy Volunteers

Healthy Volunteers

Biological: glutamate and aspartate

Other: Multiple Sclerosis patient

Multiple Sclerosis patient

Biological: glutamate and aspartate

Outcome Measures

Primary Outcome Measures

glutamate concentration (in nM) [baseline]
comparison between MS patients and controls

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 60 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

University Hospital, Caen

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

University Hospital, Caen

ClinicalTrials.gov Identifier:

NCT02523703

Other Study ID Numbers:

06-063

First Posted:

Aug 14, 2015

Last Update Posted:

Sep 2, 2020

Last Verified:

Aug 1, 2020

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Multiple Sclerosis

N-Methylaspartate

Study Results

No Results Posted as of Sep 2, 2020