Status:
COMPLETED
Proof of Principle for a Diagnostic Blood Test of Recurrent Seizures
Lead Sponsor:
Cognizance Biomarkers, LLC
Collaborating Sponsors:
University of Pennsylvania
Conditions:
Epilepsy
Eligibility:
All Genders
12+ years
Brief 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 i...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 1 2013
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 6 2018
Estimated Enrollment :
371 Patients enrolled
Trial Details
Trial ID
NCT02269397
Start Date
July 1 2013
End Date
December 6 2018
Last Update
July 31 2019
Active Locations (1)
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1
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104