Proof of Principle for a Diagnostic Blood Test of Recurrent Seizures

Cognizance Biomarkers

Status: Completed

Conditions: Epilepsy

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT02269397

817914

Details and patient eligibility

About

The primary goal of this observational study is to establish the accuracy of CNS-specific Assay for Recurrent Paroxysmal Events (CARPE) as a diagnostic blood test for epilepsy. The target population is patients who have been newly referred to the Penn Epilepsy Center or patients who are admitted to HUP for continuous video EEG monitoring. (Subjects without an epilepsy diagnosis will be included.) Subjects will be asked to provide consent, agree to allow the study team to collect information from their medical record, and to provide at least one blood sample.

Enrollment: 371 patients

Sex: All

Ages: 12+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Male/female patients aged 12 and older
• Evaluation in at least one of the following settings:
• Newly referred to the University of Pennsylvania Penn Epilepsy Center. These patients may not have completed any diagnostic evaluation at Penn, other than an initial physician consultation, prior to enrollment and must agree to allow the study team to collect records regarding their diagnostic evaluations (including EEG). Diagnostic evaluations may take place at Penn or outside sites
• All patients who are admitted to the University of Pennsylvania for continuous video EEG (cVEEG) monitoring

Exclusion criteria

• Patients who, in the opinion of the investigator or the patients neurologist, are unable to give Informed Consent due to mental impairment or any other reason AND do not have a LAR who can give Informed Consent on their behalf. Patients aged 12-17 (inclusive) must provide assent if they are mentally capable of doing so, and must also have a caregiver who provides Informed Consent on their behalf
• Patients who, in the opinion of their neurologist at the University of Pennsylvania, are not good candidates for donating blood for any reason

Trial design

371 participants in 1 patient group

Individuals with suspected epilepsy

Description:

The study will enroll individuals who are attending their first visit at the University of Pennsylvania for suspected epilepsy.