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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00264615

Enrollment

Registered

2005-12-13

Start date

2005-10-31

Completion date

2006-06-30

Last updated

2016-09-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Epilepsy

Keywords

once daily dosing, seizure, pharmacokinetics, epilepsy

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.

Interventions

DRUGlamotrigine extended-release

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Eligibility

Sex/Gender

ALL

Age

13 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
Steady state AUC(0-24), Cmax and Ct (approximate Cmin) of lamotrigine	—

Secondary

Measure	Time frame
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	—

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 6, 2026