An Exploratory Study of Genetic and Clinical Factors for Serious Skin Reactions Among Users of Eslicarbazepine Acetate
| Status: | Recruiting |
|---|---|
| Conditions: | Cosmetic |
| Therapuetic Areas: | Dermatology / Plastic Surgery |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 11/18/2018 |
| Start Date: | November 30, 2015 |
| End Date: | December 31, 2024 |
| Contact: | CNS Medical Director- |
| Phone: | 1-866-503-6351 |
An Exploratory Case-Control Study of Genetic and Clinical Factors for Serious Cutaneous Reactions Among Users of Eslicarbazepine Acetate
The purpose of 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.
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.
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.
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.
Inclusion Criteria:
- 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.
Exclusion Criteria:
We found this trial at
1
site
Philadelphia, Pennsylvania 19104
Phone: 215-898-4938
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