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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
Sponsor:
Information provided by (Responsible Party):
Sang Kun Lee, Seoul National University Hospital

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.


Condition or disease Intervention/treatment Phase
Lamotrigine Allergy Drug: Lamotrigine Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Epilepsy Rashes
Drug Information available for: Lamotrigine

Arm Intervention/treatment
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.
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.




Primary Outcome Measures :
  1. Skin rash incidence rate [ Time Frame: 2 weeks ]

Secondary Outcome Measures :
  1. Changes in Treg cell ratio in peripheral blood [ Time Frame: 2 weeks ]
  2. Severity of skin rash (CTCAE version 4.0) [ Time Frame: 2 weeks ]
  3. Lamotrigine drug level in blood (mcg/ml) [ Time Frame: 2 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

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


Locations
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Korea, Republic of
Seoul National University Hospital Recruiting
Seoul, Korea, Republic of
Contact: Sang Kun Lee, MD, PhD       sangkun2923@gmail.com   
Principal Investigator: Sang Kun Lee, MD, PhD         
Sponsors and Collaborators
Seoul National University Hospital

Publications:
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Responsible Party: Sang Kun Lee, Professor, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT03220256     History of Changes
Other Study ID Numbers: 1605-121-764
First Posted: July 18, 2017    Key Record Dates
Last Update Posted: July 18, 2017
Last Verified: July 2017

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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
Additional relevant MeSH terms:
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Lamotrigine
Epilepsy
Exanthema
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Skin Diseases
Anticonvulsants
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Sodium Channel Blockers