EpilepsyNCT01563627
Serum Profile of Inflammatory Factors, Immune and Angiogenic in Temporal Lobe Epilepsy
A study testing blood sampling for drug resistance biomarkers and Magnetic Resonance Imaging in people with Epilepsy, run by University Hospital, Montpellier at 1 site in France.
Trial summary
Epilepsy affects 0.7% of the general population and 15-20% of patients develop drug resistance. The temporal lobe epilepsy (TLE) is the most common symptomatic focal epilepsies with a particularly high rate of drug (about 20 to 30%). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Epilepsy
- What is being tested?
- blood sampling for drug resistance biomarkers and Magnetic Resonance Imaging
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteFrance
- Study dates
- Oct 2011to Sep 2013
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient with temporal lobe epilepsy (TLE)
- Patient with epilepsy for at least two years. Arm 1: Patient with drug-resistant TLE proved potentially a candidate for surgery.
- Arm 2: Patient with TLE seizure-free for 12 months or more
Who cannot join
- Patient with a scalable general pathology may lead to increased inflammatory markers: neoplasia, chronic inflammatory diseases etc. ...
- Patient with neurological history other than epilepsy with evolutionary potential or likely to interfere with the inflammatory markers
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Serum Profile of Inflammatory Factors, Immune and Angiogenic in Temporal Lobe Epilepsy: New Targets for Diagnosis and Prediction of Drug Resistance
Epilepsy affects 0.7% of the general population and 15-20% of patients develop drug resistance. The temporal lobe epilepsy (TLE) is the most common symptomatic focal epilepsies with a particularly high rate of drug (about 20 to 30%). In this type of epilepsy, where feasible, surgical removal of the home is the best therapeutic outcome.
Mechanisms of epileptogenesis and drug resistance are still mysterious. Of recent clinical and experimental studies have shown that dysfunction of the blood-brain barrier (BBB) contributes to epileptogenesis and drug resistance. It is now recognized that cytokines exacerbate the excitability and permeability of the BBB, which was recently confirmed by studies showing that treatment of inflammation reduces epileptogenesis. Moreover, we have described an association between pathological angiogenesis and BBB permeability in the tissue of patients with excision of drug-resistant TLE. With experimental models, it was revealed an activation of the VEGF-VEGFR2 by seizures leading to rapid degradation of the BBB.
The investigators hypothesis is that the identification of factors involved in BBB permeability may designate potential targets for drug-resistant partial epilepsy.
- Conditions
- Epilepsy
- Being tested
- blood sampling for drug resistance biomarkers, Magnetic Resonance Imaging
- Medical subject headings
- Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
blood sampling for drug resistance biomarkersOther
comparison of Inflammatory Factors, Immune and Angiogenic in Temporal Lobe Epilepsy
Magnetic Resonance ImagingDevice
| Study group | Role | What they receive |
|---|---|---|
| Antiepileptic Drug resistant | Experimental | Adult patients suffering from epilepsy drug-resistant and potentially surgical candidates Receives: Other: blood sampling for drug resistance biomarkers; Device: Magnetic Resonance Imaging |
| Antiepileptic drug Controlled group | Experimental | epilepsy well controlled by antiepileptic drugs Receives: Other: blood sampling for drug resistance biomarkers; Device: Magnetic Resonance Imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of Biomarkers
Identify blood sampling biomarkers of drug resistance in temporal lobe epilepsy, an analysis by large-scale expression profiling of serum factors involved in inflammation, immunity and angiogenesis
Measured: 12 months after inclusion (day 0)
Secondary outcomes (1)
permeability of the blood-brain barrier
Compare changes in lesion morphologic imaging and blood flow measurements by Magnetic Resonance Imaging between the two groups
Measured: Day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2012 (estimated)
- Study startOct 2011
- Primary completionSep 2013
- Study completionSep 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EpilepsyStudies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe 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
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01563627
- Sponsor's protocol ID
- 8668
- Status last verified
- May 2016
- First submitted
- 9 Mar 2012
- Last updated
- 1 Jun 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Serum Profile of Inflammatory Factors, Immune and Angiogenic in Temporal Lobe Epilepsy: New Targets for Diagnosis and Prediction of Drug Resistance
- ClinicalTrials.gov ID
- NCT01563627
- Acronym / sponsor ID
- 8668
- Conditions
- Epilepsy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- Oct 2011
- Primary completion
- Sep 2013 (actual)
- Study completion
- Sep 2013 (actual)
- First posted
- 27 Mar 2012 (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.
Epilepsy affects 0.7% of the general population and 15-20% of patients develop drug resistance. The temporal lobe epilepsy (TLE) is the most common symptomatic focal epilepsies with a particularly high rate of drug (about 20 to 30%). In this type of epilepsy, where feasible, surgical removal of the home is the best therapeutic outcome.
Mechanisms of epileptogenesis and drug resistance are still mysterious. Of recent clinical and experimental studies have shown that dysfunction of the blood-brain barrier (BBB) contributes to epileptogenesis and drug resistance. It is now recognized that cytokines exacerbate the excitability and permeability of the BBB, which was recently confirmed by studies showing that treatment of inflammation reduces epileptogenesis. Moreover, we have described an association between pathological angiogenesis and BBB permeability in the tissue of patients with excision of drug-resistant TLE. With experimental models, it was revealed an activation of the VEGF-VEGFR2 by seizures leading to rapid degradation of the BBB.
The investigators hypothesis is that the identification of factors involved in BBB permeability may designate potential targets for drug-resistant partial epilepsy.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Antiepileptic Drug resistant | Experimental | Other: blood sampling for drug resistance biomarkers, Device: Magnetic Resonance ImagingAdult patients suffering from epilepsy drug-resistant and potentially surgical candidates |
| Antiepileptic drug Controlled group | Experimental | Other: blood sampling for drug resistance biomarkers, Device: Magnetic Resonance Imagingepilepsy well controlled by antiepileptic drugs |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patient with temporal lobe epilepsy (TLE)
- Patient with epilepsy for at least two years. Arm 1: Patient with drug-resistant TLE proved potentially a candidate for surgery.
- Arm 2: Patient with TLE seizure-free for 12 months or more
Key exclusion criteria (2 listed)
- Patient with a scalable general pathology may lead to increased inflammatory markers: neoplasia, chronic inflammatory diseases etc. ...
- Patient with neurological history other than epilepsy with evolutionary potential or likely to interfere with the inflammatory markers
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 |
|---|---|---|
| blood sampling for drug resistance biomarkerscomparison of Inflammatory Factors, Immune and Angiogenic in Temporal Lobe Epilepsy | Other | Antiepileptic Drug resistant, Antiepileptic drug Controlled group |
| Magnetic Resonance Imaging | Device | Antiepileptic Drug resistant, Antiepileptic drug Controlled group |
Primary outcome
Comparison of Biomarkers
Time frame: 12 months after inclusion (day 0)
Identify blood sampling biomarkers of drug resistance in temporal lobe epilepsy, an analysis by large-scale expression profiling of serum factors involved in inflammation, immunity and angiogenesis
1 secondary outcome
permeability of the blood-brain barrier
Time frame: Day 0
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 1 Jun 2016.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing blood sampling for drug resistance biomarkers and Magnetic Resonance Imaging in people with Epilepsy, run by University Hospital, Montpellier at 1 site in France.
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 3 inclusion and 2 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 1 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Comparison of Biomarkers (time frame: 12 months after inclusion (day 0)). 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 1 Jun 2016.