NCT02802475

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
582

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2014

Longer than P75 for all trials

Geographic Reach
1 country

8 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2014

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

June 7, 2016

Completed
9 days until next milestone

First Posted

Study publicly available on registry

June 16, 2016

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2019

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2020

Completed
Last Updated

July 28, 2022

Status Verified

July 1, 2022

Enrollment Period

5 years

First QC Date

June 7, 2016

Last Update Submit

July 27, 2022

Conditions

Keywords

antibodiesauto-immune encephalitisepilepsylimbic encephalitis

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • modified Rankin scale

    1 year

  • Seizure frequency

    1 year

  • Treatment response

    3 months

Study Arms (2)

acquired chronic, focal, epilepsy

patients ≥18 years of age, with acquired chronic epilepsy of unknown origin

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

Biological: vena punction

Interventions

vena punctionBIOLOGICAL
acquired chronic, focal, epilepsynew onset epilepsy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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.

You may not qualify if:

  • Children
  • Epilepsy with known cause

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

Epilepsiecentrum Kempenhaeghe

Heemstede, Netherlands

Location

Stichting Epilepsie Instelling Nederland (SEIN)

Heemstede, Netherlands

Location

Academic Hospital Maastricht

Maastricht, Netherlands

Location

Erasmus Medisch Centrum

Rotterdam, Netherlands

Location

Maasstad Hospital

Rotterdam, Netherlands

Location

Haga Hospital

The Hague, Netherlands

Location

St. Elisabeth Hospital

Tilburg, Netherlands

Location

UMCU

Utrecht, Netherlands

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

serum and (if available) CSF

MeSH Terms

Conditions

EpilepsyLimbic Encephalitis

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesCentral Nervous System Viral DiseasesCentral Nervous System InfectionsInfectionsParaneoplastic Syndromes, Nervous SystemNervous System NeoplasmsNeoplasms by SiteNeoplasmsParaneoplastic SyndromesEncephalitisNeurodegenerative DiseasesNeuroinflammatory Diseases

Study Officials

  • Maarten J Titulaer, MD,PhD

    Erasmus Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD. PhD.

Study Record Dates

First Submitted

June 7, 2016

First Posted

June 16, 2016

Study Start

December 1, 2014

Primary Completion

December 1, 2019

Study Completion

December 1, 2020

Last Updated

July 28, 2022

Record last verified: 2022-07

Locations