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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 is a clinical trial that was terminated before completion, run by Sumitomo Pharma America. The registered enrollment target is 121 participants.

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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

FieldValue
Enrollment Target 121 participants
Start Date 2015-11-30
Est. Completion 2020-01-21

Sponsor

Sumitomo Pharma America

168 total trials

What the Registry Record Tells You About NCT02520557

The ClinicalTrials.gov registry entry for NCT02520557 describes a study currently listed as terminated, categorized as an unspecified phase. The registered enrollment target is 121 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Sumitomo Pharma America, which has 168 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 1 intervention - of which Blood or Saliva is the first listed.

NCT02520557 reports 0 study locations.

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.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.