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NCT00264615 Clinical Trial

Patients With Epilepsy Taking LAMICTAL Immediate-Release Who Switch To Extended-Release Formulation And Vice Versa

Epilepsy Clinical Trial

Official title:
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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00264615
Other study ID # LEP103944
Secondary ID
Status Completed
Phase Phase 3
First received December 9, 2005
Last updated September 22, 2016
Start date October 2005
Est. completion date June 2006

Study information
Verified date September 2016
Source GlaxoSmithKline
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 45
Est. completion date June 2006
Est. primary completion date June 2006
Accepts healthy volunteers No
Gender All
Age group 13 Years and older
Eligibility Inclusion criteria:

- Confident diagnosis of epilepsy.

- Currently on LAMICTAL and up to 2 concomitant AEDs (anti-epileptic drugs).

Exclusion Criteria:

- Females of childbearing potential cannot be on hormonal contraceptives or hormone replacement therapy.

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• lamotrigine extended-release

Locations
Country Name City State
United States GSK Investigational Site Anniston Alabama
United States GSK Investigational Site Boston Massachusetts
United States GSK Investigational Site Dallas Texas
United States GSK Investigational Site Lexington Kentucky
United States GSK Investigational Site Lexington Kentucky
United States GSK Investigational Site Nashville Tennessee
United States GSK Investigational Site New York New York
United States GSK Investigational Site Philadelphia Pennsylvania
United States GSK Investigational Site Reno Nevada
United States GSK Investigational Site Richmond Virginia
United States GSK Investigational Site Sun City Arizona
United States GSK Investigational Site Toledo Ohio

Sponsors (1)
Lead Sponsor Collaborator
GlaxoSmithKline

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. Epub 2007 Sep 6. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Steady state AUC(0-24), Cmax and Ct (approximate Cmin) of lamotrigine
Secondary Tmax and fluctuation index of lamotrigine
Secondary Adverse events, changes in blood pressure and heart rate
Secondary Change in seizure frequency during each of the study phases
Secondary Subject preference at End of Baseline and Extended-Release Treatment Phases
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