Protocol Establishment for the Prevention of Lamotrigine-induced Skin Rash in Epilepsy Patients
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|ClinicalTrials.gov Identifier: NCT03220256|
Recruitment Status : Unknown
Verified July 2017 by Sang Kun Lee, Seoul National University Hospital.
Recruitment status was: Recruiting
First Posted : July 18, 2017
Last Update Posted : July 18, 2017
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.
|Condition or disease||Intervention/treatment||Phase|
|Lamotrigine Allergy||Drug: Lamotrigine||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Protocol Establishment for the Prevention of Lamotrigine-induced Skin Rash in Epilepsy Patients: A Pilot Study|
|Actual Study Start Date :||August 2, 2016|
|Estimated Primary Completion Date :||August 1, 2018|
|Estimated Study Completion Date :||August 1, 2018|
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.
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.
- Skin rash incidence rate [ Time Frame: 2 weeks ]
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03220256
|Korea, Republic of|
|Seoul National University Hospital||Recruiting|
|Seoul, Korea, Republic of|
|Contact: Sang Kun Lee, MD, PhD email@example.com|
|Principal Investigator: Sang Kun Lee, MD, PhD|