SCARNCT02520557
An Exploratory Study of Genetic and Clinical Factors for Serious Skin Reactions Among Users of Eslicarbazepine Acetate
An observational study of SCAR, run by Sumitomo Pharma America, Inc. at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- SCAR
- What is being tested?
- Blood or Saliva
- How many people
- 121 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Nov 2015to 21 Jan 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Males and Females with a history of seizure disorders who may or may not develop severe skin reactions while using Eslicarbazepine
Who may be able to join
- 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.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pennsylvania Perlman School of Medicine
Philadelphia, Pennsylvania, 19104
About this study
Official title: An Exploratory Case-Control Study of Genetic and Clinical Factors for Serious Cutaneous 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 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.
Read the 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.
- Conditions
- SCAR
- Being tested
- Blood or Saliva
- Keywords
- Epilepsy, Genetic associations with severe Cutaneous Adverse Reactions
- Medical subject headings
- Cicatrix, Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood or SalivaOther
To screen for HLA genotypes that may place patients at high risk of SCAR when they use ESL.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Blood or Saliva |
What is being measured
The primary outcome is the main question the study is designed to answer.
Severe Cutaneous Adverse Reactions (SCAR) while using ESL
Measured: up to 4 months
Secondary outcomes (1)
HLA genotypes that may place patients at high risk of SCAR when they use ESL.
Measured: up to 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2015 (estimated)
- Study start30 Nov 2015
- Primary completion21 Jan 2020
- Study completion21 Jan 2020
Why it stopped: The study was not terminated for safety reasons. The sponsor was released from the postmarketing requirement to conduct the study
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SCARStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 121 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sumitomo Pharma America, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University of Pennsylvania
- Responsible party
- Sponsor
- Investigators
- CNS Medical Director, Study director, Sumitomo Pharma America, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02520557
- Sponsor's protocol ID
- SEP093-452
- Status last verified
- Jan 2021
- First submitted
- 4 Aug 2015
- Last updated
- 22 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Exploratory Case-Control Study of Genetic and Clinical Factors for Serious Cutaneous Reactions Among Users of Eslicarbazepine Acetate
- ClinicalTrials.gov ID
- NCT02520557
- Acronym / sponsor ID
- SEP093-452
- Conditions
- SCAR
- Keywords
- Epilepsy, Genetic associations with severe Cutaneous Adverse Reactions
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: The study was not terminated for safety reasons. The sponsor was released from the postmarketing requirement to conduct the study
- Enrolment
- 121 participants (actual)
- Lead sponsor
- Sumitomo Pharma America, Inc.Industry (pharma, biotech, devices)
- Collaborators
- University of Pennsylvania
- Study start
- 30 Nov 2015 (actual)
- Primary completion
- 21 Jan 2020 (actual)
- Study completion
- 21 Jan 2020 (actual)
- First posted
- 13 Aug 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Case | – | Other: Blood or SalivaCases 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. |
| Control | – | Other: Blood or SalivaControls will be individuals who have used ESL for at least 6 weeks and who have not developed SCAR. Blood draw or saliva. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Males and Females with a history of seizure disorders who may or may not develop severe skin reactions while using Eslicarbazepine
Key inclusion criteria (7 listed)
- 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.
- 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).
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood or SalivaTo screen for HLA genotypes that may place patients at high risk of SCAR when they use ESL. | Other | Case, Control |
Primary outcome
Severe Cutaneous Adverse Reactions (SCAR) while using ESL
Time frame: up to 4 months
1 secondary outcome
HLA genotypes that may place patients at high risk of SCAR when they use ESL.
Time frame: up to 4 months
Results and safety
The study was stopped early (reason given: The study was not terminated for safety reasons. The sponsor was released from the postmarketing requirement to conduct the study). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
CNS Medical Director study director
Sumitomo Pharma America, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of SCAR, run by Sumitomo Pharma America, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 22 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: The study was not terminated for safety reasons. The sponsor was released from the postmarketing requirement to conduct the study). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Severe Cutaneous Adverse Reactions (SCAR) while using ESL (time frame: up to 4 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jan 2021.