Characterization of Epilepsy Patients BEEP 2b

• Status: Completed
• Trial end date: 2018-09-04
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Food and Drug Administration (FDA)
• Collaborators: University of Maryland; University of Maryland, Baltimore
• Treatments: Anticonvulsants; Carbamazepine; Etiracetam; Lamotrigine; Levetiracetam; Oxcarbazepine; Phenytoin; Topiramate; Valproic Acid; Zonisamide

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).