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

Brief Description Of Study

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.

Clinical Study Identifier: TX1066

Detailed 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 About The Study

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.

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