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

Overview

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.

Full Title of Study: “Protocol Establishment for the Prevention of Lamotrigine-induced Skin Rash in Epilepsy Patients: A Pilot Study”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Prevention
    • Masking: None (Open Label)
  • Study Primary Completion Date: August 1, 2018

Interventions

  • Drug: 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.

Arms, Groups and Cohorts

  • Experimental: 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.

Clinical Trial Outcome Measures

Primary Measures

  • Skin rash incidence rate
    • Time Frame: 2 weeks

Secondary Measures

  • Changes in Treg cell ratio in peripheral blood
    • Time Frame: 2 weeks
  • Severity of skin rash (CTCAE version 4.0)
    • Time Frame: 2 weeks
  • Lamotrigine drug level in blood (mcg/ml)
    • Time Frame: 2 weeks

Participating in This Clinical Trial

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)

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 85 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Seoul National University Hospital
  • Provider of Information About this Clinical Study
    • Principal Investigator: Sang Kun Lee, Professor – Seoul National University Hospital

References

Wang XQ, Xiong J, Xu WH, Yu SY, Huang XS, Zhang JT, Tian CL, Huang DH, Jia WQ, Lang SY. Risk of a lamotrigine-related skin rash: current meta-analysis and postmarketing cohort analysis. Seizure. 2015 Feb;25:52-61. doi: 10.1016/j.seizure.2014.12.001. Epub 2014 Dec 23.

Murray TS, Rice TW, Wheeler AP, Phillips EJ, Dworski RT, Stollings JL. Medication Desensitization: Characterization of Outcomes and Risk Factors for Reactions. Ann Pharmacother. 2016 Mar;50(3):203-8. doi: 10.1177/1060028015625660. Epub 2016 Jan 18.

Castells M. Desensitization for drug allergy. Curr Opin Allergy Clin Immunol. 2006 Dec;6(6):476-81. doi: 10.1097/ACI.0b013e3280108716.

Akdis CA. Therapies for allergic inflammation: refining strategies to induce tolerance. Nat Med. 2012 May 4;18(5):736-49. doi: 10.1038/nm.2754.

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