Protocol Establishment for the Prevention of Lamotrigine-induced Skin Rash in Epilepsy Patients

Seoul National University

Status and phase: Unknown; Phase 2

Conditions: Lamotrigine Allergy

Treatments: Drug: Lamotrigine

Study type: Interventional

Funder types: Other

Identifiers

NCT03220256

1605-121-764

Details and patient eligibility

About

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.

Enrollment: 30 estimated patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

Lamotrigine tolerance

Experimental group

Description:

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.

Treatment:

Drug: Lamotrigine