EpilepsyIBADEPIFNCT02885207
Interest Balance Auto-immune Population in Patients With Focal Epilepsy of Unknown Cause, Not Structural, Not Genetics, Newly Diagnosed
A study testing Focal epilepsy of unknown cause in people with Epilepsy, run by University Hospital, Strasbourg, France at 4 sites in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Epilepsy
- What is being tested?
- Focal epilepsy of unknown cause
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 4 sitesFrance
- Study dates
- Jun 2015to Jul 2017
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
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- 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
Who cannot join
- 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
- IC lumbar puncture or have already received a lumbar puncture before inclusion in the protocol.
- Person under supervision or guardianship.
Trial locations and contacts
4 sites in 1 country.
DE SEZE Jérôme, MD contact
France4 sites, 4 recruiting
- Not yet recruiting
CHU de Besançon
Besançon, 25000
BERGER Eric, MD, 03 81 66 81 66, neurologie-secret@chu-besancon.fr
- Not yet recruiting
CHU de Dijon
Dijon, 21079
LEMESLE Matine, MD, 03 80 29 30 31, martine.lemesle@chu-dijon.fr
- Not yet recruiting
CHU de Nancy
Nancy, 54000
MAILLIARD Louis, MD, 03 83 85 16 09
- Recruiting
Les Hôpitaux Universitaires de Strasbourg
Strasbourg, 67091
BENOILID Aurélien, MD
About this study
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.
- Conditions
- Epilepsy
- Being tested
- Focal epilepsy of unknown cause
- Keywords
- Limbic encephalitis, anti-neuronal antibodies
- Medical subject headings
- Epilepsy, Limbic Encephalitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Focal epilepsy of unknown causeBiological
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).
| Study group | Role | What they receive |
|---|---|---|
| Focal epilepsy of unknown cause | Other | Not described Receives: Biological: Focal epilepsy of unknown cause |
What is being measured
The primary outcome is the main question the study is designed to answer.
anti-neuronal antibodies
Incidence of seropositive patients for anti-neuronal antibodies in a cohort of patients with focal epilepsy of unknown cause.
Measured: 2 years
Secondary outcomes (1)
statistically significant differences between people with and without-neuronal antibodies differences
Related to population characteristics: age, sex, ethnicity, handedness, immune dysfunction associated field, psychiatric field associated migraine associated
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2016 (estimated)
- Study startJun 2015
- Primary completionJul 2017 (estimated)
- Study completionJul 2017 (estimated)
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, Strasbourg, FranceThe 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- BENOILID Aurélien, MD, Principal investigator, not affiliated
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02885207
- Sponsor's protocol ID
- 2014-A00785-42
- Acronym
- IBADEPIF
- Status last verified
- Aug 2016
- First submitted
- 9 Oct 2014
- Last updated
- 31 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interest Balance Auto-immune Population in Patients With Focal Epilepsy of Unknown Cause, Not Structural, Not Genetics, Newly Diagnosed
- ClinicalTrials.gov ID
- NCT02885207
- Acronym / sponsor ID
- IBADEPIF / 2014-A00785-42
- Conditions
- Epilepsy
- Keywords
- Limbic encephalitis, anti-neuronal antibodies
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- Jun 2015
- Primary completion
- Jul 2017 (estimated)
- Study completion
- Jul 2017 (estimated)
- First posted
- 31 Aug 2016 (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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Focal epilepsy of unknown cause | Other | Biological: Focal epilepsy of unknown cause |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Male or female 18-65 years
- Presenting focal epilepsy on the following arguments
- Having not yet received a CSF analysis
- From unknown cause:
- Epilepsy that started within a period of two years preceding the study entry (including vegetative symptoms of temporal focal seizures).
Key exclusion criteria (8 listed)
- 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)
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 |
|---|---|---|
| Focal epilepsy of unknown causeMale 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). | Biological | Focal epilepsy of unknown cause |
Primary outcome
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.
1 secondary outcome
statistically significant differences between people with and without-neuronal antibodies differences
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2016.
- Individual participant dataSharing planned: No
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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.
DE SEZE Jérôme, MD contact
BENOILID Aurélien, MD principal investigator
not affiliated
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Focal epilepsy of unknown cause in people with Epilepsy, run by University Hospital, Strasbourg, France at 4 sites 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 14 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 31 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact BENOILID Aurélien, MD (0388128568, aurelienbenoilid@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
anti-neuronal antibodies (time frame: 2 years). 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 31 Aug 2016.