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

NCT02520557 | Terminated

• 1 other identifier: SEP093-452
• Study Type: observational
• Target: 121
• Locations: 1 country
• Sites: 1

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.

Conditions

SCAR

Keywords

Epilepsy; Genetic associations with severe Cutaneous Adverse Reactions

Outcome Measures

Primary Outcomes (1)

• Severe Cutaneous Adverse Reactions (SCAR) while using ESL

  up to 4 months

Secondary Outcomes (1)

• HLA genotypes that may place patients at high risk of SCAR when they use ESL.

  up to 4 months

Study Arms (2)

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

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

Interventions

Blood or Saliva OTHER

To screen for HLA genotypes that may place patients at high risk of SCAR when they use ESL.

Case; Control

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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.

Sponsors & Collaborators

• Sumitomo Pharma America, Inc.: lead
• University of Pennsylvania: collaborator

Study Sites (1)

University of Pennsylvania Perlman School of Medicine

Philadelphia, Pennsylvania, 19104, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Blood or Saliva

MeSH Terms

Conditions

Cicatrix; Epilepsy

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• CNS Medical Director

  Sumitomo Pharma America, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 4, 2015
• First Posted: August 13, 2015
• Study Start: November 30, 2015
• Primary Completion: January 21, 2020
• Study Completion: January 21, 2020
• Last Updated: January 22, 2021

Record last verified: 2021-01

Locations

US (1)