Skip to main content
OpenTrials
Completed

NCT Number: NCT04653571

CASPR2 Encephalitis Initial Symptoms

Auto-immune encephalitides involve auto-antibodies targeting the central nervous system, and particularly the synapse and its structure, such as protein CASPR2.

CASPR2 antibody-associated auto-immune encephalitides lead to an inflammation of the limbic system and generate focal temporal seizures and cognitive impairment. Most patients are initially hospitalized because of the temporal seizures (Joubert et al., JAMA Neurology 2016). However, many already show at that time cognitive impairment, which has failed to elicit the appropriate investigations, therefore delaying the diagnosis.

The study will hence investigate precisely the initial, sometimes neglected, clinical symptoms and those leading to the diagnosis, in the cohort of patients suffering from a CASPR2 antibody-associated encephalitis, from the French reference center on paraneoplastic neurological diseases and autoimmune encephalitis.

This way, the study aims to delineate the symptoms that should trigger suspicions of a CASPR2 antibody-associated encephalitis

Completed

Looking for future studies?

Notify Me

Key information

Conditions

CASPR2-Antibody Autoimmune Diseases Autoimmune Diseases of the Nervous System Cortical Dysplasia-Focal Epilepsy Syndrome Encephalitis Autoimmune Immune System Diseases Neoplasms Nervous System Diseases Paraneoplastic Syndromes

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Service de Neuro-Oncologie, Hôpital Neurologique Pierre Wertheimer

Bron, 69500, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Positive CASPR2-Ab in serum and/or CSF tested by immunohistochemistry on mouse brain slices and confirmed by cell-based assay (CBA) of HEK293 cells expressing CASPR2.
  • Diagnosis and follow-up in France
  • From 18 to unlimited age

Exclusion criteria

  • Patients CASPR2-IgG negative in serum and CSF
  • Foreign follow-up

Treatment and study plan

CASPR2 encephalitis

Other

Defining the initial clinical symptoms and those leading to the diagnosis of CASPR2 antibody associated encephalitis. For that, we will investigate the initial cognitive status, the initial neuropsychological investigations the clinical presentation of the first seizures, and the prodromes assessed by patients at the beginning of their disease. We will also look at the initial EEG records, in order to acknowledge whether the initial cognitive symptoms may be due to unseen seizures.

Primary outcomes

  1. Initial cognitive impairment or clinical presentation of first epileptic seizures.

    Time frame: 8 months

    The retained information will depend on the very first declared symptom: if the patient first showed focal seizures, we will precise the clinical presentation of this seizure. On the other hand, if the patient first showed cognitive symptoms, we will best define this impairment.

Sponsors and collaborators

Lead sponsor

Hospices Civils de Lyon

Other

Registry information

Official study title

Defining the Initial Clinical Symptoms and Characterizing Those Leading to the Discovery of CASPR2

Acronym: iniCASPR2

Important dates

Study start
2021
Primary completion
2021
Study completion
2022
First posted
Dec 4, 2020
Registry last updated
Feb 4, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.