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Completed

NCT Number: NCT00264615

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

Pharmacokinetic (PK) study to characterize changes in serum concentrations in epilepsy patients when switching from LAMICTAL immediate-release to extended-release and vice versa.

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Key information

Conditions

Epilepsy Brain Diseases Central Nervous System Diseases Nervous System Diseases Neurologic Manifestations Pathological Conditions, Signs and Symptoms Seizures Signs and Symptoms

Age range

13 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

GSK Investigational Site, Anniston, Alabama, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

lamotrigine extended-release

Drug

Primary outcomes

  1. Steady state AUC(0-24), Cmax and Ct (approximate Cmin) of lamotrigine

Secondary outcomes

  1. Tmax and fluctuation index of lamotrigine

  2. Adverse events, changes in blood pressure and heart rate

  3. Change in seizure frequency during each of the study phases

  4. Subject preference at End of Baseline and Extended-Release Treatment Phases

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Registry information

Official study 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

Important dates

Study start
2005
Primary completion
2006
Study completion
2006
First posted
Dec 13, 2005
Registry last updated
Sep 23, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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