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You can access this
clinical trial
if you have
Epilepsy
and you are
over 18
years old
Phase
4
The primary goal of this phase is to monitor the long-term effects.
The treatment is already on the market.
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The purpose

The United States Food and Drug Administration (FDA) has specific rules which generic drug 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 problems with the generic drugs. This research 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.

Provided treatments

  • Drug: Lamotrigine Generic "A" Lamotrigine Generic "B" Lamotrigine "Brand"
  • Drug: lamotrigine
Tris trial is registered with FDA with number: NCT01733394. The sponsor of the trial is University of Cincinnati and it is looking for 54 volunteers for the current phase.
Official trial title:
Equivalence Among Antiepileptic Drug Generic and Brand Products in People With Epilepsy: Single-Dose 6-Period Replicate Design (EQUIGEN Single-Dose Study)