NCT03220256
Unknown
Phase 2
Protocol Establishment for the Prevention of Lamotrigine-induced Skin Rash in Epilepsy Patients: A Pilot Study
Seoul National University Hospital1 site in 1 country30 target enrollmentStarted: August 2, 2016Last updated:
Overview
- Phase
- Phase 2
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- Skin rash incidence rate
Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 85 Years (Adult, Older Adult)
- Sex
- All
- Accepts 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)
Arms & Interventions
Lamotrigine tolerance
Experimental
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.
Intervention: Lamotrigine (Drug)
Outcomes
Primary Outcomes
Skin rash incidence rate
Time Frame: 2 weeks
Secondary Outcomes
- 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)
Investigators
Sang Kun Lee
Professor
Seoul National University Hospital
Study Sites (1)
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