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

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ClinicalTrials.gov Identifier: NCT02520557
Recruitment Status : Recruiting
First Posted : August 13, 2015
Last Update Posted : November 16, 2018
Sponsor:
Collaborator:
University of Pennsylvania
Information provided by (Responsible Party):
Sunovion

Brief Summary:
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.

Condition or disease Intervention/treatment
SCAR Other: Blood or Saliva

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.


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Study Type : Observational
Estimated Enrollment : 500 participants
Observational Model: Case-Control
Time Perspective: Retrospective
Official Title: An Exploratory Case-Control Study of Genetic and Clinical Factors for Serious Cutaneous Reactions Among Users of Eslicarbazepine Acetate
Actual Study Start Date : November 30, 2015
Estimated Primary Completion Date : December 31, 2024
Estimated Study Completion Date : December 31, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Scars

Group/Cohort Intervention/treatment
Case
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) 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) will be considered a potential case. Blood draw or Saliva.
Other: Blood or Saliva
To screen for HLA genotypes that may place patients at high risk of SCAR when they use ESL.

Control
Controls will be individuals who have used ESL for at least 6 weeks and who have not developed SCAR. Blood draw or saliva.
Other: Blood or Saliva
To screen for HLA genotypes that may place patients at high risk of SCAR when they use ESL.




Primary Outcome Measures :
  1. Severe Cutaneous Adverse Reactions (SCAR) while using ESL [ Time Frame: up to 4 months ]

Secondary Outcome Measures :
  1. HLA genotypes that may place patients at high risk of SCAR when they use ESL. [ Time Frame: up to 4 months ]

Biospecimen Retention:   Samples With DNA
Blood or Saliva


Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Males and Females with a history of seizure disorders who may or may not develop severe skin reactions while using Eslicarbazepine
Criteria

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:


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02520557


Contacts
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Contact: CNS Medical Director- 1-866-503-6351

Locations
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United States, Pennsylvania
University of Pennsylvania Perlman School of Medicine Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Study Coordinator    215-898-4938      
Sponsors and Collaborators
Sunovion
University of Pennsylvania
Investigators
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Study Director: CNS Medical Director Sunovion

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Responsible Party: Sunovion
ClinicalTrials.gov Identifier: NCT02520557     History of Changes
Other Study ID Numbers: SEP093-452
First Posted: August 13, 2015    Key Record Dates
Last Update Posted: November 16, 2018
Last Verified: November 2018
Keywords provided by Sunovion:
Epilepsy
Genetic associations with severe Cutaneous Adverse Reactions
Additional relevant MeSH terms:
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Eslicarbazepine acetate
Anticonvulsants
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action