Patients With Epilepsy Taking LAMICTAL Immediate-Release Who Switch To Extended-Release Formulation And Vice Versa
NCT ID: NCT00264615
Last Updated: 2016-09-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
45 participants
INTERVENTIONAL
2005-10-31
2006-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
Interventions
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lamotrigine extended-release
Eligibility Criteria
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Inclusion Criteria
* Currently on LAMICTAL and up to 2 concomitant AEDs (anti-epileptic drugs).
Exclusion Criteria
13 Years
ALL
No
Sponsors
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GlaxoSmithKline
INDUSTRY
Responsible Party
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Principal Investigators
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GSK Clinical Trials
Role: STUDY_DIRECTOR
GlaxoSmithKline
Locations
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GSK Investigational Site
Anniston, Alabama, United States
GSK Investigational Site
Sun City, Arizona, United States
GSK Investigational Site
Lexington, Kentucky, United States
GSK Investigational Site
Lexington, Kentucky, United States
GSK Investigational Site
Boston, Massachusetts, United States
GSK Investigational Site
Reno, Nevada, United States
GSK Investigational Site
New York, New York, United States
GSK Investigational Site
Toledo, Ohio, United States
GSK Investigational Site
Philadelphia, Pennsylvania, United States
GSK Investigational Site
Nashville, Tennessee, United States
GSK Investigational Site
Dallas, Texas, United States
GSK Investigational Site
Richmond, Virginia, United States
Countries
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References
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Tompson DJ, Ali I, Oliver-Willwong R, Job S, Zhu L, Lemme F, Hammer AE, Vuong A, Messenheimer JA. Steady-state pharmacokinetics of lamotrigine when converting from a twice-daily immediate-release to a once-daily extended-release formulation in subjects with epilepsy (The COMPASS Study). Epilepsia. 2008 Mar;49(3):410-7. doi: 10.1111/j.1528-1167.2007.01274.x. Epub 2007 Sep 6.
van Dijkman SC, de Jager NCB, Rauwe WM, Danhof M, Della Pasqua O. Effect of Age-Related Factors on the Pharmacokinetics of Lamotrigine and Potential Implications for Maintenance Dose Optimisation in Future Clinical Trials. Clin Pharmacokinet. 2018 Aug;57(8):1039-1053. doi: 10.1007/s40262-017-0614-5.
Study Documents
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Document Type: Annotated Case Report Form
For additional information about this study please refer to the GSK Clinical Study Register
View DocumentDocument Type: Informed Consent Form
For additional information about this study please refer to the GSK Clinical Study Register
View DocumentDocument Type: Statistical Analysis Plan
For additional information about this study please refer to the GSK Clinical Study Register
View DocumentDocument Type: Individual Participant Data Set
For additional information about this study please refer to the GSK Clinical Study Register
View DocumentDocument Type: Dataset Specification
For additional information about this study please refer to the GSK Clinical Study Register
View DocumentDocument Type: Clinical Study Report
For additional information about this study please refer to the GSK Clinical Study Register
View DocumentDocument Type: Study Protocol
For additional information about this study please refer to the GSK Clinical Study Register
View DocumentRelated Links
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Other Identifiers
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LEP103944
Identifier Type: -
Identifier Source: org_study_id
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