• Equivalence Among Anti-epileptic Drug Generic and Brand Products in People with Epilepsy-Chronic Dose 4-period Replicate Design: EQUIGEN Chronic-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-Chronic 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 lamotrigine products. Each subject will be randomized to take one generic lamotrigine for two weeks and then be switched to another generic lamotrigine for a two week period. Each of the lamotrigine products will be given twice, giving a total of 4 different study periods.

Eligibility Criteria Include:

1) Anyone who is on a stable medication regimen. You cannot change your medications while in the study.
2) Taking conventional (not extended release) Lamotrigine at the following doses ONLY: 100 mg twice a day, 200 mg twice a day, 300 mg twice a day, or 400mg twice a day.
3) Can be on polytherapy (more than one seizure medication) EXCLUDING DEPAKOTE.

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, CRC
Phone  – 617-732-5423