Characterization of Epilepsy Patients BEEP 2b
Condition: Epilepsy
MeSH terms: Epilepsy
Study type: Interventional
Phase: Phase 1

Summary: 
      Some epilepsy patients are described as GB when they have worsened seizures or side effects
      related to switching between brand name and generic, or between generic antiepileptic drug
      (AED) products. In concert with Aim 1 (protocol BEEP2a), this study will uncover possible
      reasons for patient problems with the drug switching. Factors that will be studied in GB
      epilepsy patients include physiologic, psychological, and genetic factors, including in this
      protocol whether brand and generic AEDs are pharmacokinetically similar in GB individuals.
    

Detailed description: 
      This pilot study is exploratory research to characterize the "generic brittle" (GB) patient
      and to identify major causes for generic brittleness in epilepsy patients who are sensitive
      to antiepileptic drug (AED) formulation changes.

      The primary aim of this BEEP2b study is to perform individual pharmacokinetic (PK) similarity
      testing of brand and generic AEDs in "probably GB" patients (N=12),who were selected on the
      basis of having GB-defining factors from the BEEP2a study, in order to confirm whether these
      factors are predictive of a generic brittle response to product switching. The study design
      involves a randomized, double-blind, multiple-dose, complete four-way replicate crossover
      design in which one brand and one generic will be compared in each patient from the patient's
      own AED regimen. Associated adverse events (i.e. seizures and side effects) will also be
      assessed. Bioequivalence (BE) will not be assessed. Rather, about nine AEDs are expected to
      be collectively evaluated. Generic brittleness anticipates that, for individual subjects,
      brand and generic may be the same or different, depending upon the underlying basis for
      generic brittleness. This exploratory research is focused on understanding individual patient
      attributes that contribute to GB, and is not focused on either product development or
      comparison of specific products.
    

Intervention name(s): Oxcarbazepine (brand name vs generic drugs); Divalproex Sodium (brand name vs generic drugs); Carbamazepine (brand name vs generic drugs); Lamotrigine (brand name vs generic drugs); levetiracetam (brand name vs generic drugs); Topiramate (brand name vs generic drugs); Zonisamide (brand name vs generic drugs); Phenytoin sodium (brand name vs generic drugs)
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): This is a cross-over replicate study with 2 sequences (arms) comparing brand name and generic anti-epileptic drugs. Subjects will take a brand name and a generic drug of the same intervention. While there are only 2 sequences, there are 8 possible drugs for this study, and a study patient will only take 1 out of 8 study drugs. Only pharmacists will know which sequence each patient is assigned to.; This is a cross-over replicate study with 2 sequences (arms) comparing brand name and generic anti-epileptic drugs. Subjects will take a brand name and a generic drug of the same intervention. While there are only 2 sequences, there are 8 possible drugs for this study, and a study patient will only take 1 out of 8 study drugs. Only pharmacists will know which sequence each patient is assigned to.; This is a cross-over replicate study with 2 sequences (arms) comparing brand name and generic anti-epileptic drugs. Subjects will take a brand name and a generic drug of the same intervention. While there are only 2 sequences, there are 8 possible drugs for this study, and a study patient will only take 1 out of 8 study drugs. Only pharmacists will know which sequence each patient is assigned to.; This is a cross-over replicate study with 2 sequences (arms) comparing brand name and generic anti-epileptic drugs. Subjects will take a brand name and a generic drug of the same intervention. While there are only 2 sequences, there are 8 possible drugs for this study, and a study patient will only take 1 out of 8 study drugs. Only pharmacists will know which sequence each patient is assigned to.; This is a cross-over replicate study with 2 sequences (arms) comparing brand name and generic anti-epileptic drugs. Subjects will take a brand name and a generic drug of the same intervention. While there are only 2 sequences, there are 8 possible drugs for this study, and a study patient will only take 1 out of 8 study drugs. Only pharmacists will know which sequence each patient is assigned to.; This is a cross-over replicate study with 2 sequences (arms) comparing brand name and generic anti-epileptic drugs. Subjects will take a brand name and a generic drug of the same intervention. While there are only 2 sequences, there are 8 possible drugs for this study, and a study patient will only take 1 out of 8 study drugs. Only pharmacists will know which sequence each patient is assigned to.; This is a cross-over replicate study with 2 sequences (arms) comparing brand name and generic anti-epileptic drugs. Subjects will take a brand name and a generic drug of the same intervention. While there are only 2 sequences, there are 8 possible drugs for this study, and a study patient will only take 1 out of 8 study drugs. Only pharmacists will know which sequence each patient is assigned to.; This is a cross-over replicate study with 2 sequences (arms) comparing brand name and generic anti-epileptic drugs. Subjects will take a brand name and a generic drug of the same intervention. While there are only 2 sequences, there are 8 possible drugs for this study, and a study patient will only take 1 out of 8 study drugs. Only pharmacists will know which sequence each patient is assigned to.
Intervention MeSH terms: Topiramate; Lamotrigine; Zonisamide; Carbamazepine; Phenytoin; Oxcarbazepine; Levetiracetam; Valproic Acid
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Generic brittle; Anti-epileptic drug; Bioequivalence