Lamotrigine Allergy
Conditions
Brief summary
The investigators intend to find a way to lower drug rash occurrence by applying drug tolerance induction protocol at the beginning of lamotrigine administration. Genotyping of participants with rash and those without rash after taking lamotrigine and genetic testing to find common gene mutations in these participants.
Interventions
DRUGLamotrigine
The dose of lamotrigine (0.1mg) started to increase and gradually increased according to the drug tolerance induction protocol, and the efficacy was evaluated by dosing to the commercial capacity (100mg bid) within 2 weeks. In addition, the ratio of regulatory T cells was measured before lamotrigine administration, and the proportion of regulatory T cells was measured by two-week administration of lamotrigine after tolerance induction protocol. Add 6 ml of EDTA tube to each cryovial, and dispense 1 ml each in cryovial. After the appropriate number of patients of the same phenotype were collected, the analysis was performed.
Sponsors
Seoul National University Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* Adults aged 18-85 years old * Epilepsy patients * Patients who started Lamotrigine first time
Exclusion criteria
* Those who do not agree with prior consent * Women taking oral contraceptives. * history of drug rash * Taking enzyme-inducing antiepileptic drugs (EIAED) or valproate (VPA)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Skin rash incidence rate | 2 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Changes in Treg cell ratio in peripheral blood | 2 weeks |
| Severity of skin rash (CTCAE version 4.0) | 2 weeks |
| Lamotrigine drug level in blood (mcg/ml) | 2 weeks |
Countries
South Korea
Outcome results
None listed