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

NCT02523703 | Completed

• 1 other identifier: 06-063
• Study Type: interventional
• Target: 36
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Multiple Sclerosis

Outcome Measures

Primary Outcomes (1)

• glutamate concentration (in nM)

  comparison between MS patients and controls

  baseline

Study Arms (2)

Healthy Volunteers

OTHER

Healthy Volunteers

Biological: glutamate and aspartate

Multiple Sclerosis patient

OTHER

Multiple Sclerosis patient

Biological: glutamate and aspartate

Interventions

glutamate and aspartate BIOLOGICAL

Healthy Volunteers; Multiple Sclerosis patient

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• Secondary progressive MS
• Any cons-indication for lumbar puncture
• Any contra-indication to MRI
• Minor patient or patient major under guardianship

Sponsors & Collaborators

• University Hospital, Caen: lead

MeSH Terms

Conditions

Multiple Sclerosis

Interventions

Glutamic Acid; Aspartic Acid

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Glutamates; Amino Acids, Acidic; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Dicarboxylic; Excitatory Amino Acids

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 13, 2015
• First Posted: August 14, 2015
• Study Start: September 10, 2007
• Primary Completion: February 15, 2012
• Study Completion: February 23, 2015
• Last Updated: September 2, 2020

Record last verified: 2020-08