Interest Balance Auto-immune Population in Patients With Focal Epilepsy of Unknown Cause, Not Structural, Not Genetics, Newly Diagnosed
IBADEPIF
1 other identifier
interventional
200
1 country
4
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jun 2015
Typical duration for not_applicable
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 9, 2014
CompletedStudy Start
First participant enrolled
June 1, 2015
CompletedFirst Posted
Study publicly available on registry
August 31, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2017
CompletedAugust 31, 2016
August 1, 2016
2.1 years
October 9, 2014
August 25, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
anti-neuronal antibodies
Incidence of seropositive patients for anti-neuronal antibodies in a cohort of patients with focal epilepsy of unknown cause.
2 years
Secondary Outcomes (1)
statistically significant differences between people with and without-neuronal antibodies differences
2 years
Other Outcomes (2)
Serum analysis:(composite measure)
2 years
CSF analysis (composite measure)
2 years
Study Arms (1)
Focal epilepsy of unknown cause
OTHERInterventions
Male or female 18-65 years presenting focal epilepsy on the following arguments: * Crisis with clinical symptoms indicating focal seizure * \& / Or crisis or critical focal inter-recorded EEG interpreted by a neurologist with expertise in the field of epilepsy. From unknown cause: * No evidence of injury (excluding temporal or hyperintensity of hippocampal sclerosis) on brain MRI with focus on regions of interest cuts. * No discharge or generalized photosensitivity recorded over an extended interpreted by a neurologist with expertise in the field of epilepsy video-EEG. * No argument for metabolic or neurodegenerative genetic epilepsy. * Normal neurological examination. Epilepsy that started within a maximum period of 2 years prior to inclusion in the study (including vegetative symptoms of temporal focal seizures). Without treatment by benzodiazepines or anti-epileptics first-line monotherapy (excluding benzodiazepines).
Eligibility Criteria
You may qualify if:
- Male or female 18-65 years
- Presenting focal epilepsy on the following arguments
- Crisis with clinical symptoms indicating focal seizure
- \& / Or crisis or critical focal inter-recorded on EEG interpreted by a neurologist with expertise in the field of epilepsy.
- Having not yet received a CSF analysis
- From unknown cause:
- No evidence of injury (excluding temporal or hyperintensity of hippocampal sclerosis) on brain MRI with focus on regions of interest cuts.
- No discharge or generalized photosensitivity recorded over an extended interpreted by a neurologist with expertise in the field of epilepsy video-EEG.
- No argument for metabolic or neurodegenerative genetic epilepsy.
- Normal neurological examination.
- Epilepsy that started within a period of two years preceding the study entry (including vegetative symptoms of temporal focal seizures).
- Without treatment or as benzodiazepines or taking anti-epileptic first-line monotherapy (excluding benzodiazepines).
- Informed consent signed
- affiliated with a social security scheme
You may not qualify if:
- structural abnormality found in brain MRI (except temporal hyperintensity and / or sclerosis of the hippocampus).
- Background Neurological: hyperthermic seizures in childhood, neonatal distress, history of seizures related to a circumstance, inflammation or infection of the CNS.
- Taking toxic: chronic alcoholism, narcotic consumption
- The case for a genetic / metabolic neurodeg ear /: generalized EEG / photosensitivity / family history of epilepsy / autism / disorder syndrome psychomotor development / dysmorphic syndrome / extrapyramidal syndrome associated discharge
- History of thyroiditis or m. system (LEAD, SGS, PR, Sarcoidosis)
- Immunosuppression innate or acquired
- Person under supervision or guardianship.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (4)
CHU de Besançon
Besançon, 25000, France
CHU de Dijon
Dijon, 21079, France
CHU de Nancy
Nancy, 54000, France
Les Hôpitaux Universitaires de Strasbourg
Strasbourg, 67091, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
BENOILID Aurélien, MD
not affiliated
Central Study Contacts
DE SEZE Jérôme, MD
CONTACT
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 9, 2014
First Posted
August 31, 2016
Study Start
June 1, 2015
Primary Completion
July 1, 2017
Study Completion
July 1, 2017
Last Updated
August 31, 2016
Record last verified: 2016-08
Data Sharing
- IPD Sharing
- Will not share