Proof of Principle for a Diagnostic Blood Test of Recurrent Seizures

Epilepsy Clinical Trial

Official title:

Proof of Principle for a Diagnostic Blood Test of Recurrent Seizures

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02269397
• Other study ID #: 817914
• Status: Completed
• Start date: July 2013
• Est. completion date: December 6, 2018

Study information

• Verified date: July 2019
• Source: Cognizance Biomarkers, LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 371
• Est. completion date: December 6, 2018
• Est. primary completion date: July 14, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Epilepsy
• Seizures

Locations

Country	Name	City	State
United States	University of Pennsylvania	Philadelphia	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Cognizance Biomarkers, LLC	University of Pennsylvania

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Epilepsy diagnosis (CARPE) blood test for determining the presence of epilepsy ad in doing so, determine the threshold for diagnosis	Epilepsy diagnosis determined by three epileptologist's review of subject's medical records	2 years