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Antibodies Causing Epilepsy Syndromes: The ACES Study. (ACES)

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ClinicalTrials.gov Identifier: NCT02802475
Recruitment Status : Recruiting
First Posted : June 16, 2016
Last Update Posted : September 6, 2018
Sponsor:
Collaborator:
Nationaal Epilepsie Fonds
Information provided by (Responsible Party):
M.J. Titulaer, Erasmus Medical Center

Tracking Information
First Submitted Date June 7, 2016
First Posted Date June 16, 2016
Last Update Posted Date September 6, 2018
Study Start Date December 2014
Estimated Primary Completion Date January 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: June 13, 2016)
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
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT02802475 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: June 13, 2016)
  • modified Rankin scale [ Time Frame: 1 year ]
    outcome 1 year after inclusion in the study
  • Seizure frequency [ Time Frame: 1 year ]
    seizure frequency 1 year after inclusion in the study
  • Treatment response [ Time Frame: 3 months ]
    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.
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Antibodies Causing Epilepsy Syndromes: The ACES Study.
Official Title Antibodies Causing Epilepsy Syndromes: The ACES Study.
Brief 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.
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 Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples Without DNA
Description:
serum and (if available) CSF
Sampling Method Non-Probability Sample
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.
Condition
  • Auto-immune Encephalitis
  • Epilepsy
Intervention Biological: vena punction
Study Groups/Cohorts
  • acquired chronic, focal, epilepsy
    patients ≥18 years of age, with acquired chronic epilepsy of unknown origin
    Intervention: 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
    Intervention: Biological: vena punction
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: June 13, 2016)
1000
Original Estimated Enrollment Same as current
Estimated Study Completion Date July 2019
Estimated Primary Completion Date January 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria

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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Marienke AA de Bruijn, MD 0031628306007 aces@erasmusmc.nl
Contact: Maarten J Titulaer, MD, PhD 0031628306007 aces@erasmusmc.nl
Listed Location Countries Netherlands
Removed Location Countries  
 
Administrative Information
NCT Number NCT02802475
Other Study ID Numbers MEC 2014-463
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party M.J. Titulaer, Erasmus Medical Center
Study Sponsor Erasmus Medical Center
Collaborators Nationaal Epilepsie Fonds
Investigators
Principal Investigator: Maarten J Titulaer, MD,PhD Erasmus Medical Center
PRS Account Erasmus Medical Center
Verification Date September 2018