Epilepsy Clinical Trial
Official title:
HLA Screening in Reducing the Risk of Antiepileptic Drug-induced Cutaneous Adverse Reactions: a Multicenter Clinical Study
Cutaneous adverse drug reactions (cADRs) include mild maculopapular exanthema (MPE) and
severe cutaneous reactions such as hypersensitivity syndrome, Stevens-Johnson syndrome (SJS),
and toxic epidermal necrolysis (TEN). cADRs are considered as a major public health issue
because of their potentially life-threatening morbidity, especially severe cutaneous
reactions. The incidence of SJS/TEN is estimated to vary from 1 in 1,000 to 10,000 drug
exposures, and its mortality is as high as 35%. Antiepileptic drugs (AEDs), particularly
those with aromatic ring structures such as carbamazepine (CBZ), oxcarbazepine (OXC),
lamotrigine (LTG), phenobarbital (PB), and phenytoin (PHT), are among the most common causes
of severe cutaneous reactions. The incidence of AED-induced SJS was estimated as 0.2% and all
cases occurred in individuals receiving aromatic AEDs.
Previous studies have validated that the human leukocyte antigen (HLA) allele HLA-B*15:02 is
strongly associated with CBZ-induced SJS/TEN in southern Han Chinese and populations in
southeast Asia. Our recent studies indicated that HLA-A*24:02 is a common genetic risk factor
for CBZ-, LTG-, and PHT-induced SJS/TEN. It is also associated with MPE. Additionally,
another four alleles, including HLA-B*15:01, HLA-B*15:11, HLA-A*02:01,and HLA-DRB1*01:01,
were showed to be potential risk factors for aromatic AEDs-induced SJS/TEN. In 2007, the US
Food and Drug Administration issued the safety alert that recommended HLA-B*15:02 screening
for people with Asian ancestry before starting CBZ, and avoidance of the drug if the test is
positive. Subsequent studies from Taiwan, Hong Kong and Thailand demonstrated that
HLA-B*15:02 screening before commencing CBZ can significantly reduce the incidence of
CBZ-induced SJS/TEN. However, the overall incidence of AEDs-induced SJS/TEN remained
unchanged in Hong Kong, as PHT-induced SJS/TEN increased when CBZ-SJS/TEN decreased.
Moreover, no study focuses on the incidences of AEDs-induced cADRs with and without HLA
screening before commencing aromatic AEDs. Therefore, we are planning to conduct a
multicenter prospective study to examine the reduction of AEDs-induced cADRs after the HLA
screening prior to the beginning of aromatic AEDs administration.
In this prospective study, 4000 or more patients from multicenters in southern China will be recruited. A HLA screening will be conducted before these patients start aromatic AEDs treatments. According to the HLA genotype, these patients will be divided into four groups that are three positive groups with different risk alleles and one negative group with no known risk allele. Aromatic AEDs were avoided or administrated with caution according to the risk level in the three positive groups, while they can be prescribed in the negative group. The effectiveness of HLA screening prior to the beginning of aromatic AEDs administration will be observed by the reduction of overall incidence of AEDs-induced cADRs. ;
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT04595513 -
Stopping TSC Onset and Progression 2: Epilepsy Prevention in TSC Infants
|
Phase 1/Phase 2 | |
Completed |
NCT02909387 -
Adapting Project UPLIFT for Blacks in Georgia
|
N/A | |
Completed |
NCT05552924 -
Self Acupressure on Fatigue and Sleep Quality in Epilepsy Patients
|
N/A | |
Terminated |
NCT01668654 -
Long-term, Open-label Safety Extension Study of Retigabine/Ezogabine in Pediatric Subjects (>= 12 Years Old) With POS or LGS
|
Phase 3 | |
Not yet recruiting |
NCT05068323 -
Impact of Interictal Epileptiform Activity on Some Cognitive Domains in Newly Diagnosed Epileptic Patients
|
N/A | |
Completed |
NCT03994718 -
Creative Arts II Study
|
N/A | |
Recruiting |
NCT04076449 -
Quantitative Susceptibility Biomarker and Brain Structural Property for Cerebral Cavernous Malformation Related Epilepsy
|
||
Completed |
NCT00782249 -
Trial Comparing Different Stimulation Paradigms in Patients Treated With Vagus Nerve Stimulation for Refractory Epilepsy
|
N/A | |
Completed |
NCT03683381 -
App-based Intervention for Treating Insomnia Among Patients With Epilepsy
|
N/A | |
Recruiting |
NCT05101161 -
Neurofeedback Using Implanted Deep Brain Stimulation Electrodes
|
N/A | |
Active, not recruiting |
NCT06034353 -
Impact of Pharmacist-led Cognitive Behavioral Intervention on Adherence and Quality of Life of Epileptic Patients
|
N/A | |
Recruiting |
NCT05769933 -
Bridging Gaps in the Neuroimaging Puzzle: New Ways to Image Brain Anatomy and Function in Health and Disease Using Electroencephalography and 7 Tesla Magnetic Resonance Imaging
|
||
Not yet recruiting |
NCT06408428 -
Glioma Intraoperative MicroElectroCorticoGraphy
|
N/A | |
Not yet recruiting |
NCT05559060 -
Comorbidities of Epilepsy(Cognitive and Psychiatric Dysfunction)
|
||
Completed |
NCT02952456 -
Phenomenological Approach of Epilepsy in Patients With Epilepsy
|
||
Completed |
NCT02977208 -
Impact of Polymorphisms of OCT2 and OCTN1 on the Kinetic Disposition of Gabapentin in Patients Undergoing Chronic Use
|
Phase 4 | |
Completed |
NCT02646631 -
Behavioral and Educational Tools to Improve Epilepsy Care
|
N/A | |
Recruiting |
NCT02539134 -
TAK-935 Multiple Rising Dose Study in Healthy Participants
|
Phase 1 | |
Terminated |
NCT02757547 -
Transcranial Magnetic Stimulation for Epilepsy
|
N/A | |
Completed |
NCT02491073 -
Study to Evaluate Serum Free Thyroxine (FT4) and Free Triiodothyronine (FT3) Measurements for Subjects Treated With Eslicarbazeine Acetate (ESL)
|
N/A |