Characterization of Epilepsy Patients BEEP 2b
Condition: Epilepsy
MeSH terms: Epilepsy
Intervention: 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 description: 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
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 21.0
Sex: All
Minimum age: 18 Years
Maximum age: 76 Years
Healthy volunteers: No
Keywords: Generic brittle; Anti-epileptic drug; Bioequivalence

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.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Subject previously completed BEEP2a study, found to be probably GB, and able to
             provide informed consent or subject's legally authorized representative is able to
             provide informed consent.

          2. Subject is male or female between 18 and 76 years of age inclusive.

          3. Subject has a diagnosis of epilepsy including focal or primary generalized epilepsy.

          4. Subject is taking at least one study antiepileptic drug for the treatment of epilepsy.

          5. Subject is an acceptable candidate for venipuncture.

          6. Subject is willing to be switched between brand and generic drug.

          7. Subject is willing to stop all non-routine OTC medications for 24 hours prior to and
             during pharmacokinetic study visits.

          8. Subject is willing to maintain stable doses of all other AEDs, including Vagus Nerve
             Stimulation parameters for the duration of the study.

        Exclusion Criteria:

          1. Subject has any medical condition, including a progressive neurological condition,
             which in the opinion of the investigator, could jeopardize the subject's health or
             would compromise the subject's ability to participate in the trial.

          2. Subject has a history of alcohol or drug abuse, which in the opinion of the
             investigator, could jeopardize the subject's health or would compromise the subject's
             ability to participate in this trial.

          3. Subject has a history of previous or current significant psychiatric disorder that
             would interfere with conduct of the study.

          4. Subject is pregnant or lactating.

          5. Subject has severe liver impairment as assessed by alanine aminotransferase (ALT),
             aspartate aminotransferase (AST), or total bilirubin levels ≥10 times the upper limit
             of normal (ULN).

          6. Subject has severe renal impairment as assessed by creatinine clearance lower than
             30mL/min, using the Cockcroft-Gault formula.

          7. Female subjects of childbearing potential will not be eligible to participate who are
             unwilling or unable to use a medically acceptable method of contraception throughout
             the entire study period and for one week after the study is completed. Medically
             acceptable methods of contraception that may be used by the subject and/or her partner
             are: condom with spermicide, diaphragm with spermicide, IUD without progesterone,
             vaginal spermicidal suppository, surgical sterilization of their partner(s) or
             abstinence.

          8. Subject is not willing or able to be adherent to study protocol (e.g. study medication
             dosing and any interacting comedication).