An Exploratory Case-Control Study of Genetic and Clinical Factors For Serious Cutaneous Reactions Among Users of Eslicarbazepine Acetate

Site Image

Study Overview

Eslicarbazepine acetate (Aptiom®) is an antiepileptic drug (AED) approved in the United States (US) as adjunctive therapy for the treatment of partial-onset seizures in adults .Prior research has shown that seizure medicines like carbamazepine (Tegretol®) and oxcarbazepine (Trileptal®, Oxtellar®) are more likely to cause severe drug related skin reactions in some people of Asian ancestry who have specific genes. These are genes found in an area of your chromosomes (packaging for your genes) called the Major Histocompatibility Complex. This association is called a genetic risk factor.

Study Description

We plan to compare information that we obtained from participants who take Aptiom® and have not experienced a severe skin reaction to a group of patients who also have a history of seizure disorders and do have a history of a severe skin reaction after using Aptiom®. We will ask participants for a sample of their Deoxyribonucleic Acid (DNA). This sample can be obtained from saliva (spit). We will ask for information about skin reactions and medications. We plan to enroll about 500 individuals with a history of seizures who used Aptiom® and who did not have a severe skin reaction, and 25 participants who have used Aptiom® and experienced a severe skin reaction.

Additional Information:

Individuals who have used Aptiom® for at least 6 weeks and have not developed SCAR are eligible to be a control in this study. Individuals who have had a severe skin reaction while taking Aptiom® can participate as a case in this study.

  • Study Identifier: 823267

Recruitment Status

Open

Contact the research team to learn more about this study.

Fields marked with asterisk (*) are required

Please verify that you are not a bot.

By clicking "Contact Research Team", your contact information will be sent securely to the research staff associated with the study. You will also receive a copy of this email in your inbox, as well as other notifications to determine your participation status in the study.

Volunteer Sign up

Volunteer Sign-up

Participate in medical studies to develop new diagnostic and clinical treatments and improve current standards of care.

Sign Up Now!

If you need assistance finding a non-cancer study or if you have any questions, please email psom-ocr@pobox.upenn.edu