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

Lamotrigine Allergy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03220256
• Other study ID #: 1605-121-764
• Status: Recruiting
• Phase: Phase 2
• First received: July 12, 2017
• Last updated: July 14, 2017
• Start date: August 2, 2016
• Est. completion date: August 1, 2018

Study information

• Verified date: July 2017
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: August 1, 2018
• Est. primary completion date: August 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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)

Related Conditions & MeSH terms

• Epilepsy
• Exanthema
• Lamotrigine Allergy

Intervention

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.

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (4)

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. Review. — View Citation

Castells M. Desensitization for drug allergy. Curr Opin Allergy Clin Immunol. 2006 Dec;6(6):476-81. Review. — View Citation

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. — View Citation

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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Skin rash incidence rate		2 weeks
Secondary	Changes in Treg cell ratio in peripheral blood		2 weeks
Secondary	Severity of skin rash (CTCAE version 4.0)		2 weeks
Secondary	Lamotrigine drug level in blood (mcg/ml)		2 weeks