Equigen is a bioequivalency trial comparing a branded vs. generic antiepileptic. The trial is being conducted at 3 sites, with each enrolling 12 subjects each. Johns Hopkins' Brain Injury Outcomes team is serving as a coordinating center for this 18-month trial.
The United States Food and Drug Administration (FDA) has specific rules which pharmaceutical companies must follow to get a generic copy of a seizure medication approved. Currently, FDA approves generic drugs by requiring studies on normal volunteers who don't have epilepsy and who take just one dose of the generic drug followed by a series of blood tests. Some people with epilepsy and their physicians have complained about side effects or loss of seizure control when taking generic drugs, but no one knows if these complaints are truly because of any possible difference between the generic and branded (trade name) drugs.
This series of clinical trials is to determine whether several different generic versions and the brand version of the medication lamotrigine perform in a similar way when given to people with epilepsy. The study drug, Lamictal® (lamotrigine), and both of the generic forms of lamotrigine to be tested are approved by the FDA for the treatment of seizures.
EQUIGEN is composed of two sister, bioequivalency trials. The EQUIGEN Chronic Dose trial is comparing two generics of lamotrigine. The trial is being conducted at 6 sites, with each enrolling approximately 6 subjects each over 12 months.
The EQUIGEN Single Dose trial is comparing Lamictal® with two generics of lamotrigine. The trial is being conducted at 5 sites, with each enrolling approximately 11 subjects each over 12 months.
For both trials, the University of Cincinnati has contracted with the Johns Hopkins Brain Injury Outcomes team (BIOS) to serve as the Coordinating Center and the Kansas University Medical Center to serve as the Data Management Center.