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NCT02520557
An Exploratory Study of Genetic and Clinical Factors for Serious Skin Reactions Among Users of Eslicarbazepine Acetate
trial testing Blood or Saliva in SCAR in 121 participants. Terminated before completion.
21 January 2020
Quick facts
| Lead sponsor | Sumitomo Pharma America, Inc. |
|---|---|
| Status | Terminated |
| Study type | OBSERVATIONAL |
| Enrollment | 121 |
| Start date | 30 November 2015 |
| Primary completion | 21 January 2020 |
| Estimated completion | 21 January 2020 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Blood or Saliva
Conditions studied
- SCAR — all drugs for SCAR →
Sponsor
Sumitomo Pharma America, Inc. — full company profile →
Who can join
Eligibility, any sex, with SCAR. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT02520557
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT02520557 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Sumitomo Pharma America, Inc.
- Last refreshed: 22 January 2021
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02520557.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing