Multiple SclerosisEXCEEDNCT02523703
Excitotoxicity Markers and the Clinical-radiological Progression After a Demyelinating Event: a Prospective Pilot Study
A study testing glutamate and aspartate in people with Multiple Sclerosis, run by University Hospital, Caen.
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)… Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- glutamate and aspartate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- No sites listed yet
- Study dates
- 10 Sep 2007to 23 Feb 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- Secondary progressive MS
- Any cons-indication for lumbar puncture
- Any contra-indication to MRI
- Minor patient or patient major under guardianship
About this study
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
- Being tested
- glutamate and aspartate
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
glutamate and aspartateBiological
| Study group | Role | What they receive |
|---|---|---|
| Healthy Volunteers | Other | Healthy Volunteers Receives: Biological: glutamate and aspartate |
| Multiple Sclerosis patient | Other | Multiple Sclerosis patient Receives: Biological: glutamate and aspartate |
What is being measured
The primary outcome is the main question the study is designed to answer.
glutamate concentration (in nM)
comparison between MS patients and controls
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2015 (estimated)
- Study start10 Sep 2007
- Primary completion15 Feb 2012
- Study completion23 Feb 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- More trials run by University Hospital, CaenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Caen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02523703
- Sponsor's protocol ID
- 06-063
- Acronym
- EXCEED
- Status last verified
- Aug 2020
- First submitted
- 13 Aug 2015
- Last updated
- 2 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Excitotoxicity Markers and the Clinical-radiological Progression After a Demyelinating Event: a Prospective Pilot Study
- ClinicalTrials.gov ID
- NCT02523703
- Acronym / sponsor ID
- EXCEED / 06-063
- Conditions
- Multiple Sclerosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- University Hospital, CaenUniversity, hospital or other
- Study start
- 10 Sep 2007 (actual)
- Primary completion
- 15 Feb 2012 (actual)
- Study completion
- 23 Feb 2015 (actual)
- First posted
- 14 Aug 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healthy Volunteers | Other | Biological: glutamate and aspartateHealthy Volunteers |
| Multiple Sclerosis patient | Other | Biological: glutamate and aspartateMultiple Sclerosis patient |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (4 listed)
- Secondary progressive MS
- Any cons-indication for lumbar puncture
- Any contra-indication to MRI
- Minor patient or patient major under guardianship
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| glutamate and aspartate | Biological | Healthy Volunteers, Multiple Sclerosis patient |
Primary outcome
glutamate concentration (in nM)
Time frame: baseline
comparison between MS patients and controls
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing glutamate and aspartate in people with Multiple Sclerosis, run by University Hospital, Caen.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
glutamate concentration (in nM) (time frame: baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Sep 2020.