Protocol Establishment for the Prevention of Lamotrigine-induced Skin Rash in Epilepsy Patients
- Registration Number
- NCT03220256
- Lead Sponsor
- Seoul National University Hospital
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 30
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)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Lamotrigine tolerance Lamotrigine 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.
- Primary Outcome Measures
Name Time Method Skin rash incidence rate 2 weeks
- Secondary Outcome Measures
Name Time Method Lamotrigine drug level in blood (mcg/ml) 2 weeks Severity of skin rash (CTCAE version 4.0) 2 weeks Changes in Treg cell ratio in peripheral blood 2 weeks
Trial Locations
- Locations (1)
Seoul National University Hospital
🇰🇷Seoul, Korea, Republic of