Interest Balance Auto-immune Population in Patients With Focal Epilepsy of Unknown Cause, Not Structural, Not Genetics, Newly Diagnosed (IBADEPIF)
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|ClinicalTrials.gov Identifier: NCT02885207|
Recruitment Status : Unknown
Verified August 2016 by University Hospital, Strasbourg, France.
Recruitment status was: Recruiting
First Posted : August 31, 2016
Last Update Posted : August 31, 2016
The knowledge of encephalitis associated with antibodies targeting intracellular antigens, and neuronal surface antibody syndromes has expanded considerably in recent times.
The primary purpose of the investigators protocole is to determine the incidence of anti-neuronal antibodies (blood and CSF) in a population of patients suffering from focal epilepsy of unknown cause to guide the management of these patients.
The investigators hypothesis is that dysimmune encephalitis is more common than is suggested by the current literature, and that sometimes forms of encephalitis dysimmune "at minimum" can be observed only in the form of focal epilepsy without further manifestation associated.
|Condition or disease||Intervention/treatment||Phase|
|Epilepsy||Biological: Focal epilepsy of unknown cause||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||200 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Interest Balance Auto-immune Population in Patients With Focal Epilepsy of Unknown Cause, Not Structural, Not Genetics, Newly Diagnosed|
|Study Start Date :||June 2015|
|Estimated Primary Completion Date :||July 2017|
|Estimated Study Completion Date :||July 2017|
|Focal epilepsy of unknown cause||
Biological: Focal epilepsy of unknown cause
Male or female 18-65 years presenting focal epilepsy on the following arguments:
From unknown cause:
Without treatment by benzodiazepines or anti-epileptics first-line monotherapy (excluding benzodiazepines).
- anti-neuronal antibodies [ Time Frame: 2 years ]Incidence of seropositive patients for anti-neuronal antibodies in a cohort of patients with focal epilepsy of unknown cause.
- statistically significant differences between people with and without-neuronal antibodies differences [ Time Frame: 2 years ]Related to population characteristics: age, sex, ethnicity, handedness, immune dysfunction associated field, psychiatric field associated migraine associated
- Serum analysis:(composite measure) [ Time Frame: 2 years ]Directed by a blood test on a peripheral vein: ANA, anti-ENA, anti-DNA, ANCA, anti-TPO, anti-TGO, APL, anti-GAD, anti-transglutaminase / anti-Hu, Yo, Ri, CV2 , amphiphysin, Ma2 / VGKC complex, anti-NMDA-R, anti-AMPA-R, anti-GABA B-R / Other: NFS, CRP, ESR, TSH, PT, APTT
- CSF analysis (composite measure) [ Time Frame: 2 years ]A lumbar puncture is performed under strict aseptic conditions, in the absence cons classic indications (abnormal crushes or platelet count) in hospital, followed by monitoring at least three hours, looking for: ac neurons anti / Finding an oligoclonal distribution (DOC, immunoglobulin synthesis intrathéquale) / WBC and red blood cells, protein level
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02885207
|Contact: BENOILID Aurélien, MDfirstname.lastname@example.org|
|Contact: DE SEZE Jérôme, MD|
|CHU de Besançon||Not yet recruiting|
|Besançon, France, 25000|
|Contact: BERGER Eric, MD 03 81 66 81 66 email@example.com|
|CHU de Dijon||Not yet recruiting|
|Dijon, France, 21079|
|Contact: LEMESLE Matine, MD 03 80 29 30 31 firstname.lastname@example.org|
|CHU de Nancy||Not yet recruiting|
|Nancy, France, 54000|
|Contact: MAILLIARD Louis, MD 03 83 85 16 09|
|Les Hôpitaux Universitaires de Strasbourg||Recruiting|
|Strasbourg, France, 67091|
|Principal Investigator: BENOILID Aurélien, MD|
|Principal Investigator:||BENOILID Aurélien, MD||not affiliated|