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

Primary Purpose

Multiple Sclerosis

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
glutamate and aspartate
Sponsored by
University Hospital, Caen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Multiple Sclerosis

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Other

    Other

    Arm Label

    Healthy Volunteers

    Multiple Sclerosis patient

    Arm Description

    Healthy Volunteers

    Multiple Sclerosis patient

    Outcomes

    Primary Outcome Measures

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

    Secondary Outcome Measures

    Full Information

    First Posted
    August 13, 2015
    Last Updated
    August 31, 2020
    Sponsor
    University Hospital, Caen
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02523703
    Brief Title
    Excitotoxicity Markers and the Clinical-radiological Progression After a Demyelinating Event: a Prospective Pilot Study
    Acronym
    EXCEED
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2020
    Overall Recruitment Status
    Completed
    Study Start Date
    September 10, 2007 (Actual)
    Primary Completion Date
    February 15, 2012 (Actual)
    Study Completion Date
    February 23, 2015 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    University Hospital, Caen

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Multiple Sclerosis

    7. Study Design

    Primary Purpose
    Basic Science
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    36 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Healthy Volunteers
    Arm Type
    Other
    Arm Description
    Healthy Volunteers
    Arm Title
    Multiple Sclerosis patient
    Arm Type
    Other
    Arm Description
    Multiple Sclerosis patient
    Intervention Type
    Biological
    Intervention Name(s)
    glutamate and aspartate
    Primary Outcome Measure Information:
    Title
    glutamate concentration (in nM)
    Description
    comparison between MS patients and controls
    Time Frame
    baseline

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    60 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    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

    12. IPD Sharing Statement

    Learn more about this trial

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

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