Antibodies Causing Epilepsy Syndromes: The ACES Study.

Epilepsy Clinical Trial

— ACES  

Official title:

Antibodies Causing Epilepsy Syndromes: The ACES Study.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02802475
• Other study ID #: MEC 2014-463
• Status: Completed
• Start date: December 2014
• Est. completion date: December 2020

Study information

• Verified date: July 2022
• Source: Erasmus Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 582
• Est. completion date: December 2020
• Est. primary completion date: December 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• Children

• Epilepsy with known cause

Related Conditions & MeSH terms

• Auto-immune Encephalitis
• Encephalitis
• Epilepsy
• Epileptic Syndromes

Intervention

Biological:
• vena punction

Locations

Country	Name	City	State
Netherlands	Epilepsiecentrum Kempenhaeghe	Heemstede
Netherlands	Stichting Epilepsie Instelling Nederland (SEIN)	Heemstede
Netherlands	Academic Hospital Maastricht	Maastricht
Netherlands	Erasmus Medisch Centrum	Rotterdam
Netherlands	Maasstad Hospital	Rotterdam
Netherlands	Haga Hospital	The Hague
Netherlands	St. Elisabeth Hospital	Tilburg
Netherlands	UMCU	Utrecht

Sponsors (2)

Lead Sponsor	Collaborator
Erasmus Medical Center	Nationaal Epilepsie Fonds

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	3 year
Secondary	modified Rankin scale	outcome 1 year after inclusion in the study	1 year
Secondary	Seizure frequency	seizure frequency 1 year after inclusion in the study	1 year
Secondary	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.	3 months