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

NCT02520557 · Status: TERMINATED · Type: OBSERVATIONAL · Enrollment: 121

Last updated 2021-01-22

No results posted yet for this study

Summary

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.

Conditions

  • SCAR

Interventions

OTHER

Blood or Saliva

To screen for HLA genotypes that may place patients at high risk of SCAR when they use ESL.

Sponsors & Collaborators

Principal Investigators

  • CNS Medical Director · Sumitomo Pharma America, Inc.

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-11-30
Primary Completion
2020-01-21
Completion
2020-01-21

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02520557 on ClinicalTrials.gov