• Equivalence among Antiepileptic Drug Generic and Brand Products in People with Epilepsy: Single-Dose 6-Period Replicate Design (EQUIGEN Single-Dose Study)
The data available to the United States Food and Drug Administration (FDA) supports bioequivalence of approved brand and generic drugs and suggest that generic anti-epileptic drugs (AEDs) can be safely interchanged with the brand product or other generic products. However, the risks and benefits of generic substitution may not be fully understood. Some patients and physicians have expressed concern that some generic AEDs are not identical in controlling seizures and avoiding adverse effects at the same dose.

The EQUIGEN Single-Dose Research Study is a prospective, multi-center, randomized trial in people with epilepsy. Carefully studying a population of people with epilepsy is more likely to reveal if switching among products has or does not have a clinical effect.

The study will be done at Brigham & Women's Hospital (BWH) in Boston and will compare 2 different generic lamotrigine versions and the brand name version in people with Epilepsy. Each subject will receive a single dose of the study drug every 2 weeks at the beginning of a 12 hour study study visit. Each of the lamotrigine versions will be given twice, giving a total of 6 different study periods.

Subjects will be compensated for study participation. Hotel stays will be covered by the study the night before the 12 hour hospital visits.

Eligibility Criteria Include:

1) Anyone who is on a stable medication regimen. You cannot change your medications while in the study.
2) Be diagnosed with Epilepsy for at least 1 year
3) Currently taking any anti-seizure medication EXCEPT DEPAKOTE AND THE STUDY DRUG LAMOTRIGINE
4) Cannot be on Sertraline (Zoloft) or any estrogen-containing medications

For more information about this study, please contact Nichelle Llewellyn, the Epilepsy Research Coordinator, at (617) 732-5423, or email her at epilepsyresearch@partners.org
Institution  –  BWH - Brigham and Women's Hospital, Boston, MA
Principal Investigator  – Barbara A Dworetzky, MD
Enrollment Information
For further information about enrolling a patient in this trial, contact the person below.
Name  – Nichelle Llewellyn
Phone  – 617-732-5423