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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-08-02

Study Completion Date

2018-08-01

Brief Summary

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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.

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Detailed Description

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Conditions

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Lamotrigine Allergy

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Lamotrigine tolerance

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.

Group Type EXPERIMENTAL

Lamotrigine

Intervention Type DRUG

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.

Interventions

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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. 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.

Intervention Type DRUG

Eligibility Criteria

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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)

Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No