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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
NameTimeMethod
Steady state AUC(0-24), Cmax and Ct (approximate Cmin) of lamotrigine
Secondary Outcome Measures
NameTimeMethod
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

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