Overview

This trial is active, not recruiting.

Condition epilepsy
Sponsor Cognizance Biomarkers, LLC
Collaborator University of Pennsylvania
Start date July 2013
End date July 2016
Trial size 240 participants
Trial identifier NCT02269397, 817914

Summary

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective
Arm
The study will enroll individuals who are attending their first visit at the University of Pennsylvania for suspected epilepsy.

Primary Outcomes

Measure
Epilepsy diagnosis (CARPE) blood test for determining the presence of epilepsy ad in doing so, determine the threshold for diagnosis
time frame: 2 years

Eligibility Criteria

Male or female participants at least 12 years old.

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

Additional Information

Official title Proof of Principle for a Diagnostic Blood Test of Recurrent Seizures
Trial information was received from ClinicalTrials.gov and was last updated in August 2015.
Information provided to ClinicalTrials.gov by Cognizance Biomarkers, LLC.