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NCT02520557 · ClinicalTrials.gov registry record
An Exploratory Study of Genetic and Clinical Factors for Serious Skin Reactions Among Users of Eslicarbazepine Acetate
A clinical trial, sponsored by Sumitomo Pharma America.
- Terminated
- Registry status
- 121
- Enrollment target
NCT02520557: Clinical Trial study, sponsored by Sumitomo Pharma America.
NCT02520557 is a clinical trial that was terminated before completion, run by Sumitomo Pharma America. The registered enrollment target is 121 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02520557 was terminated before completion, sponsored by Sumitomo Pharma America.
- TERMINATED
- Registry status
- 121 participants
- Enrollment target
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.
Interventions
- OTHER Blood or Saliva
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 121 participants |
| Start Date | 2015-11-30 |
| Est. Completion | 2020-01-21 |
Why NCT02520557 stopped before completion
NCT02520557 is an observational study that tracks outcomes without assigning an intervention. The registered 121 participants enrollment target is mid-sized for trials with a published cap.
The record links to 0 conditions, and to 1 intervention - of which Blood or Saliva is the first listed.
NCT02520557 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02520557 about?
NCT02520557 is a clinical study titled "An Exploratory Study of Genetic and Clinical Factors for Serious Skin Reactions Among Users of Eslicarbazepine Acetate". 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 de...
What is the current status of trial NCT02520557?
This trial is currently terminated. The enrollment target is 121 participants. The study started on 2015-11-30. Estimated completion is 2020-01-21.
What interventions are being tested in trial NCT02520557?
The interventions under investigation include: Blood or Saliva (OTHER).
Who is sponsoring clinical trial NCT02520557?
This trial is sponsored by Sumitomo Pharma America, which has 168 total clinical trials registered on ClinicalTrials.gov.
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