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

Primary Purpose

Lamotrigine Allergy

Status
Unknown status
Phase
Phase 2
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Lamotrigine
Sponsored by
Seoul National University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Lamotrigine Allergy

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept 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)

Sites / Locations

  • Seoul National University HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Lamotrigine tolerance

Arm 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.

Outcomes

Primary Outcome Measures

Skin rash incidence rate

Secondary Outcome Measures

Changes in Treg cell ratio in peripheral blood
Severity of skin rash (CTCAE version 4.0)
Lamotrigine drug level in blood (mcg/ml)

Full Information

First Posted
July 12, 2017
Last Updated
July 14, 2017
Sponsor
Seoul National University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03220256
Brief Title
Protocol Establishment for the Prevention of Lamotrigine-induced Skin Rash in Epilepsy Patients
Official Title
Protocol Establishment for the Prevention of Lamotrigine-induced Skin Rash in Epilepsy Patients: A Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
July 2017
Overall Recruitment Status
Unknown status
Study Start Date
August 2, 2016 (Actual)
Primary Completion Date
August 1, 2018 (Anticipated)
Study Completion Date
August 1, 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul National University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lamotrigine Allergy

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Lamotrigine tolerance
Arm Type
Experimental
Arm 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.
Intervention Type
Drug
Intervention Name(s)
Lamotrigine
Intervention 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. 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.
Primary Outcome Measure Information:
Title
Skin rash incidence rate
Time Frame
2 weeks
Secondary Outcome Measure Information:
Title
Changes in Treg cell ratio in peripheral blood
Time Frame
2 weeks
Title
Severity of skin rash (CTCAE version 4.0)
Time Frame
2 weeks
Title
Lamotrigine drug level in blood (mcg/ml)
Time Frame
2 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Facility Information:
Facility Name
Seoul National University Hospital
City
Seoul
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sang Kun Lee, MD, PhD
Email
sangkun2923@gmail.com
First Name & Middle Initial & Last Name & Degree
Sang Kun Lee, MD, PhD

12. IPD Sharing Statement

Citations:
PubMed Identifier
25645637
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.
Results Reference
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PubMed Identifier
26783356
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.
Results Reference
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PubMed Identifier
17088655
Citation
Castells M. Desensitization for drug allergy. Curr Opin Allergy Clin Immunol. 2006 Dec;6(6):476-81. doi: 10.1097/ACI.0b013e3280108716.
Results Reference
background
PubMed Identifier
22561837
Citation
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.
Results Reference
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Protocol Establishment for the Prevention of Lamotrigine-induced Skin Rash in Epilepsy Patients

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