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

NCT03220256 | Unknown Phase 2 DMC

• 1 other identifier: 1605-121-764
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Lamotrigine Allergy

Outcome Measures

Primary Outcomes (1)

• Skin rash incidence rate

  2 weeks

Secondary Outcomes (3)

• Changes in Treg cell ratio in peripheral blood

  2 weeks

• Severity of skin rash (CTCAE version 4.0)

  2 weeks

• Lamotrigine drug level in blood (mcg/ml)

  2 weeks

Study Arms (1)

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.

Drug: Lamotrigine

Interventions

Lamotrigine 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.

Lamotrigine tolerance

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults aged 18-85 years old
• Epilepsy patients
• Patients who started Lamotrigine first time

You may not qualify if:

• 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)

Sponsors & Collaborators

• Seoul National University Hospital: lead

Study Sites (1)

Seoul National University Hospital

Seoul, South Korea

RECRUITING

Related Publications (4)

• 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.

  PMID: 25645637 BACKGROUND

• 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.

  PMID: 26783356 BACKGROUND

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

  PMID: 17088655 BACKGROUND

• 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.

  PMID: 22561837 BACKGROUND

MeSH Terms

Interventions

Lamotrigine

Intervention Hierarchy (Ancestors)

Triazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 12, 2017
• First Posted: July 18, 2017
• Study Start: August 2, 2016
• Primary Completion: August 1, 2018
• Study Completion: August 1, 2018
• Last Updated: July 18, 2017

Record last verified: 2017-07

Locations

KR (1)