Patients With Epilepsy Taking LAMICTAL Immediate-Release Who Switch To Extended-Release Formulation And Vice Versa
An Open-label, Double Conversion Study to Characterize the Pharmacokinetics of Lamotrigine When Switching Patients With Epilepsy on LAMICTAL Immediate-release to Extended-release Formulation and Vice Versa
1 other identifier
interventional
45
1 country
12
Brief Summary
Pharmacokinetic (PK) study to characterize changes in serum concentrations in epilepsy patients when switching from LAMICTAL immediate-release to extended-release and vice versa.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Oct 2005
Shorter than P25 for phase_3
12 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2005
CompletedFirst Submitted
Initial submission to the registry
December 9, 2005
CompletedFirst Posted
Study publicly available on registry
December 13, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2006
CompletedSeptember 23, 2016
September 1, 2016
8 months
December 9, 2005
September 22, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Steady state AUC(0-24), Cmax and Ct (approximate Cmin) of lamotrigine
Secondary Outcomes (4)
Tmax and fluctuation index of lamotrigine
Adverse events, changes in blood pressure and heart rate
Change in seizure frequency during each of the study phases
Subject preference at End of Baseline and Extended-Release Treatment Phases
Interventions
Eligibility Criteria
You may qualify if:
- Confident diagnosis of epilepsy.
- Currently on LAMICTAL and up to 2 concomitant AEDs (anti-epileptic drugs).
You may not qualify if:
- Females of childbearing potential cannot be on hormonal contraceptives or hormone replacement therapy.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- GlaxoSmithKlinelead
Study Sites (12)
GSK Investigational Site
Anniston, Alabama, 36207, United States
GSK Investigational Site
Sun City, Arizona, 85351, United States
GSK Investigational Site
Lexington, Kentucky, 40503, United States
GSK Investigational Site
Lexington, Kentucky, 40536-0284, United States
GSK Investigational Site
Boston, Massachusetts, 02215, United States
GSK Investigational Site
Reno, Nevada, 89521, United States
GSK Investigational Site
New York, New York, 10016, United States
GSK Investigational Site
Toledo, Ohio, 43614-5809, United States
GSK Investigational Site
Philadelphia, Pennsylvania, 19140, United States
GSK Investigational Site
Nashville, Tennessee, 37232, United States
GSK Investigational Site
Dallas, Texas, 75230, United States
GSK Investigational Site
Richmond, Virginia, 23219, United States
Related Publications (2)
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.
PMID: 17825077BACKGROUNDvan 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.
PMID: 29363050DERIVED
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
GSK Clinical Trials
GlaxoSmithKline
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NON RANDOMIZED
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 9, 2005
First Posted
December 13, 2005
Study Start
October 1, 2005
Primary Completion
June 1, 2006
Study Completion
June 1, 2006
Last Updated
September 23, 2016
Record last verified: 2016-09
Data Sharing
- IPD Sharing
- Will share
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.