Ignite Creation Date:
2025-12-24 @ 6:59 PM
Ignite Modification Date:
2026-01-01 @ 11:13 PM
Study NCT ID:
NCT02520557
Status:
TERMINATED
Last Update Posted:
2021-01-22
First Post:
2015-08-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
An Exploratory Study of Genetic and Clinical Factors for Serious Skin Reactions Among Users of Eslicarbazepine Acetate
Sponsor:
Sumitomo Pharma America, Inc.
Organization:
Study Overview
Official Title:
An Exploratory Case-Control Study of Genetic and Clinical Factors for Serious Cutaneous Reactions Among Users of Eslicarbazepine Acetate
Status:
TERMINATED
Status Verified Date:
2021-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
The study was not terminated for safety reasons. The sponsor was released from the postmarketing requirement to conduct the study
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
Detailed Description:
This study is a genetic case-control study conducted in the United States. In case-control studies, cases with a condition of interest (in this case, individuals with SCAR \[severe cutaneous adverse reactions\] after initiating ESL); and controls, individuals known to not have the condition of interest (in this case ESL users without SCAR), are identified. Cases will be individuals with documented definite or probable Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), acute generalized exanthematous pustulosis (AGEP), drug reaction with eosinophilia and systemic symptoms (DRESS) or symptom onset consistent with one of these conditions within the first 4 months of using ESL (including up to 14 days after discontinuing ESL), ascertained through PPD Pharmacovigilance (PVG) (Sponsor CRO). Controls will be individuals who have used ESL for at least 6 weeks but did not develop any SCAR and will be matched by genetic ancestry classification in a ratio of up to 10 controls per case. Controls will be collected prospectively, so that a pool of ESL-tolerant patients will be identified independently of the collection of cases. Controls will be selected from among:
* Ongoing subjects in clinical studies of ESL; and
* Patients prescribed ESL who may be asked to participate by neurologists at high-prescribing practices with high ethnic diversity.
Blood or saliva samples for genotyping ancestry markers (for matching controls to cases) and sequencing the HLA regions will be collected from cases and control subjects after they have provided consent for participation in a genetic study. In addition, a blood sample will be requested from subjects to assess the relationship with specific viral markers.
* Ongoing subjects in clinical studies of ESL; and
* Patients prescribed ESL who may be asked to participate by neurologists at high-prescribing practices with high ethnic diversity.
Blood or saliva samples for genotyping ancestry markers (for matching controls to cases) and sequencing the HLA regions will be collected from cases and control subjects after they have provided consent for participation in a genetic study. In addition, a blood sample will be requested from subjects to assess the relationship with specific viral markers.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: