In this study, brand name lamotrigine (LAMICTAL) and generic lamotrigine will be compared in
patients with epilepsy. Both the brand name and generic lamotrigine are approved by the Food
and Drug Administration (FDA) and are commonly used to treat epilepsy. Some physicians and
patients with epilepsy have believed that brand and generic lamotrigine have had clinically
significant differences in efficacy and tolerability. The brand name and generic tablets have
been shown to be the same when blood levels were measured in healthy volunteers without
epilepsy, but these drugs have not yet been compared in patients with epilepsy. This study
will do this comparison, by switching patients between brand and generic in a very structured
manner, and seeing if the drugs are the same, primarily in terms of blood levels. Other
comparisons will also be made secondarily, looking for any differences in adverse effects and
seizure control.
Phase:
Phase 4
Details
Lead Sponsor:
University of Maryland University of Maryland, Baltimore