Patients With Epilepsy Taking LAMICTAL Immediate-Release Who Switch To Extended-Release Formulation And Vice Versa
Phase 3
Completed
- Conditions
- Epilepsy
- Registration Number
- NCT00264615
- Lead Sponsor
- GlaxoSmithKline
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 45
Inclusion Criteria
Not provided
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Exclusion Criteria
- Females of childbearing potential cannot be on hormonal contraceptives or hormone replacement therapy.
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Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Steady state AUC(0-24), Cmax and Ct (approximate Cmin) of lamotrigine
- Secondary Outcome Measures
Name Time Method 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
Trial Locations
- Locations (1)
GSK Investigational Site
🇺🇸Richmond, Virginia, United States