Auto-immune EncephalitisACESNCT02802475
Antibodies Causing Epilepsy Syndromes: The ACES Study.
An observational study of Auto-immune Encephalitis and Epilepsy, run by Erasmus Medical Center at 8 sites in Netherlands.
Trial summary
The Antibodies Causing Epilepsy Syndromes (ACES) Study is a observational cohort study focusing on detection of auto-immune epilepsy in patients with epilepsy of unknown origin. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Auto-immune Encephalitis, Epilepsy
- What is being tested?
- vena punction
- How many people
- 582 participants
- Where
- 8 sitesNetherlands
- Study dates
- Dec 2014to Dec 2020
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adults with acquired chronic focal epilepsy without known cause or new onset status epilepticus or new onset seizures with signs of encephalitis and unknown cause.
Who may be able to join
- Age of 18 and older.
- Status epilepticus or new onset seizures with signs of limbic encephalitis (clinical picture, MRI (FLAIR abnormalities), EEG abnormalities or CSF findings (CSF pleocytosis, increased IgG index, oligoclonal bands), or:
- Patients with acquired chronic focal epilepsy with an unknown cause.
Who cannot join
- Children
- Epilepsy with known cause
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
Netherlands8 sites
Epilepsiecentrum Kempenhaeghe
Heemstede
Stichting Epilepsie Instelling Nederland (SEIN)
Heemstede
Academic Hospital Maastricht
Maastricht
Erasmus Medisch Centrum
Rotterdam
Maasstad Hospital
Rotterdam
Haga Hospital
The Hague
St. Elisabeth Hospital
Tilburg
UMCU
Utrecht
About this study
The Antibodies Causing Epilepsy Syndromes (ACES) Study is a observational cohort study focusing on detection of auto-immune epilepsy in patients with epilepsy of unknown origin.
Read the detailed description
Recently new treatable causes of epilepsy have been identified. These disorders are caused by a disruption of the balance in the brain caused by inflammation. This inflammatory reaction is caused by an autologous reaction of the immune system to specific brain proteins. The body produces antibodies to specific parts of the brain. These disorders can lead to epilepsy, memory dysfunction and psychiatric problems. Recognition is necessary for good treatment. Mostly anti-epileptic drugs are insufficient. These diseases can be treated with immune-modulating therapy. The ACES Study will focus on determining the frequencies of known antibodies and finding new, currently unknown, antibodies, causing epilepsy. Therefore patients will be investigated with epilepsy of unknown origin. To find new antibodies sera of patients with epilepsy will be added to brain sections of rats and to cultivated neuronal cells to look for a reaction. If new antibodies will be detected clinical features will be mapped of the patients. Also effects of antibodies on brain cells will be determined. Discovery of new antibodies can provide new treatment options for these patients. Also it will enable to discover more about the pathologic mechanisms of epilepsy.
- Conditions
- Auto-immune Encephalitis, Epilepsy
- Being tested
- vena punction
- Keywords
- antibodies, auto-immune encephalitis, epilepsy, limbic encephalitis
- 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.
vena punctionBiological
| Study group | Role | What they receive |
|---|---|---|
| acquired chronic, focal, epilepsy | patients ≥18 years of age, with acquired chronic epilepsy of unknown origin Receives: Biological: vena punction | |
| new onset epilepsy | patients ≥18 years of age, with new onset status epilepticus or new onset seizures with suspicion of limbic encephalitis Receives: Biological: vena punction |
What is being measured
The primary outcome is the main question the study is designed to answer.
frequency of patients with known and novel antibodies
detection of specific known and novel, currently unknown, auto-antibodies by immunohistochemistry, live hippocampal neuron cultures and cell-based assay
Measured: 3 year
Secondary outcomes (3)
modified Rankin scale
outcome 1 year after inclusion in the study
Measured: 1 year
Seizure frequency
seizure frequency 1 year after inclusion in the study
Measured: 1 year
Treatment response
frequency of objective improvement of outcome (seizure frequency, modified Rankin Scale) after immunotherapy, as compared to matched controls (without antibodies) from our study to exclude an effect due to regression to the mean or natural nistory.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2016 (estimated)
- Study startDec 2014
- Primary completionDec 2019
- Study completionDec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Auto-immune EncephalitisStudies of the same condition, open and under way.
- More trials run by Erasmus Medical CenterThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 582 participants (actual)
Sponsor and investigators
- Lead sponsor
- Erasmus Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Nationaal Epilepsie Fonds
- Responsible party
- Principal investigator, M.J. Titulaer, Erasmus Medical Center
- Investigators
- Maarten J Titulaer, MD,PhD, Principal investigator, Erasmus Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02802475
- Sponsor's protocol ID
- MEC 2014-463
- Acronym
- ACES
- Status last verified
- Jul 2022
- First submitted
- 7 Jun 2016
- Last updated
- 28 Jul 2022
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Antibodies Causing Epilepsy Syndromes: The ACES Study.
- ClinicalTrials.gov ID
- NCT02802475
- Acronym / sponsor ID
- ACES / MEC 2014-463
- Conditions
- Auto-immune Encephalitis, Epilepsy
- Keywords
- antibodies, auto-immune encephalitis, epilepsy, limbic encephalitis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 582 participants (actual)
- Lead sponsor
- Erasmus Medical CenterUniversity, hospital or other
- Collaborators
- Nationaal Epilepsie Fonds
- Study start
- Dec 2014 (actual)
- Primary completion
- Dec 2019 (actual)
- Study completion
- Dec 2020 (actual)
- First posted
- 16 Jun 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 Antibodies Causing Epilepsy Syndromes (ACES) Study is a observational cohort study focusing on detection of auto-immune epilepsy in patients with epilepsy of unknown origin.
Detailed description
Recently new treatable causes of epilepsy have been identified. These disorders are caused by a disruption of the balance in the brain caused by inflammation. This inflammatory reaction is caused by an autologous reaction of the immune system to specific brain proteins. The body produces antibodies to specific parts of the brain. These disorders can lead to epilepsy, memory dysfunction and psychiatric problems. Recognition is necessary for good treatment. Mostly anti-epileptic drugs are insufficient. These diseases can be treated with immune-modulating therapy. The ACES Study will focus on determining the frequencies of known antibodies and finding new, currently unknown, antibodies, causing epilepsy. Therefore patients will be investigated with epilepsy of unknown origin. To find new antibodies sera of patients with epilepsy will be added to brain sections of rats and to cultivated neuronal cells to look for a reaction. If new antibodies will be detected clinical features will be mapped of the patients. Also effects of antibodies on brain cells will be determined. Discovery of new antibodies can provide new treatment options for these patients. Also it will enable to discover more about the pathologic mechanisms of epilepsy.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| acquired chronic, focal, epilepsy | – | Biological: vena punctionpatients ≥18 years of age, with acquired chronic epilepsy of unknown origin |
| new onset epilepsy | – | Biological: vena punctionpatients ≥18 years of age, with new onset status epilepticus or new onset seizures with suspicion of limbic encephalitis |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults with acquired chronic focal epilepsy without known cause or new onset status epilepticus or new onset seizures with signs of encephalitis and unknown cause.
Key inclusion criteria (3 listed)
- Age of 18 and older.
- Status epilepticus or new onset seizures with signs of limbic encephalitis (clinical picture, MRI (FLAIR abnormalities), EEG abnormalities or CSF findings (CSF pleocytosis, increased IgG index, oligoclonal bands), or:
- Patients with acquired chronic focal epilepsy with an unknown cause.
Key exclusion criteria (2 listed)
- Children
- Epilepsy with known cause
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 |
|---|---|---|
| vena punction | Biological | acquired chronic, focal, epilepsy, new onset epilepsy |
Primary outcome
frequency of patients with known and novel antibodies
Time frame: 3 year
detection of specific known and novel, currently unknown, auto-antibodies by immunohistochemistry, live hippocampal neuron cultures and cell-based assay
3 secondary outcomes
modified Rankin scale
Time frame: 1 year
Seizure frequency
Time frame: 1 year
Treatment response
Time frame: 3 months
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 28 Jul 2022.
Related trials for Auto-immune Encephalitis
Active, not recruitingObservational study
New Biomarkers in Auto-immune Encephalitis and Neurological Paraneoplastic Syndromes
Paraneoplastic Neurological Syndrome, Autoimmune Encephalitis
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.
Maarten J Titulaer, MD,PhD principal investigator
Erasmus Medical Center
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Auto-immune Encephalitis and Epilepsy, run by Erasmus Medical Center at 8 sites in Netherlands.
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 28 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Netherlands. 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?
frequency of patients with known and novel antibodies (time frame: 3 year). 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 28 Jul 2022.