An Exploratory Study of Genetic and Clinical Factors for Serious Skin Reactions Among Users of Eslicarbazepine Acetate

Stopped early

Conditions studied: SCAR

In brief

The reason for this study is to understand if people with certain genes are predisposed to develop severe skin reactions after they are administered Eslicarbazepine Acetate. Currently there is no information that suggests that certain individuals who use Eslicarbazepine Acetate are predisposed to develop severe skin reactions. However, previous research has shown that seizure medicines like carbamazepine (Tegretol®) and oxcarbazepine (Trileptal®, Oxtellar XR®) 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 chromosomes called the Major Histocompatibility Complex. This association is called a genetic risk factor. The study objective is to compare information that is obtained from individuals with a history of seizure disorders who develop severe skin reactions while using Eslicarbazepine Acetate to a group of patients who also have a history of seizure disorders and do not have a history of a severe skin reaction after using Eslicarbazepine Acetate.

Key facts

Study ID

NCT02520557

Run by

Sumitomo Pharma America, Inc.

People needed

121

Starts

2015-11-30

Expected to finish

2020-01-21

Last updated by the study team

2021-01-22

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Study subjects must have the ability to comprehend the informed consent and be willing to provide informed consent and consent for storage and DNA testing of blood or saliva. For subjects who are unable to comprehend the written consent, a legal guardian who is able to describe and provide an understanding of the informed consent to the subject must sign all study consent forms on behalf of the subject.
• The study subject or parent/guardian must possess an educational level and degree of understanding of English or Spanish that enables them to communicate suitably with the local investigator and study coordination staff.
• Specific criteria for cases and controls:
• Cases will be individuals with documented definite or probable Stevens-Johnson syndrome (SJS)
• Toxic epidermal necrolysis (TEN), acute generalized exanthematous pustulosis (AGEP), or drug reaction with eosinophilia and systemic symptoms (DRESS)
• Symptom onset consistent with one of these conditions within the first 4 months of using ESL (including up to 14 days after discontinuing ESL).
• Controls will be individuals who have used ESL for at least 6 weeks and who have not developed SCAR.

Where it is running

• University of Pennsylvania Perlman School of Medicine — Philadelphia, Pennsylvania, United States

Full record on ClinicalTrials.gov

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