Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Randomized, Double-blind, Placebo-controlled, Parallel Group, Multi-center Trial Of Pregabalin Controlled Release Formulation As Adjunctive Therapy In Adults With Partial Onset Seizures
Brief Summary: Approximately 30% percent of subjects with partial seizures are refractory to treatment with single or combination antiepileptic drugs. The present study will compare the efficacy of two different dosages of pregabalin CR dosed once daily as compared to placebo, when used as adjunctive therapy in subjects requiring adjunctive therapy for partial onset epilepsy, using a randomized, parallel group design.


Options:
A: Inclusion Criteria:

* Diagnosis of epilepsy with partial onset seizures (seizures may be simple or complex, with or without evolution into a bilateral, convulsive seizure)
* Currently taking 1 to 3 anti-epilepsy medicines (AEDs) at stable dosages, and who have taken at least 2 prior (or ongoing) AEDs

Exclusion Criteria:

* Primary generalized seizures (for example, absence, myoclonic seizures or Lennox-Gastaut Syndrome)
* Status epilepticus within one year prior to screening
B: Inclusion Criteria:

* Male/female from 16 to 65 years
* Well-characterized focal epilepsy or epileptic syndrome according to the International League Against Epilepsy (ILAE) classification
* History of partial onset seizures
* Subjects having at least 4 partial onset seizures during the 4-week Baseline Period and at least 2 partial onset seizures during the 3 months prior to Visit 1
* Subjects taking 1 or 2 concomitant Antiepileptic drugs (AED(s)) that have been at a stable dose.

Exclusion Criteria:

* Seizure type IA non-motor as only seizure type
* Seizures occurring only in clusters
* Status epilepticus during the last 2 years before Visit 1
* History of cerebrovascular accident (CVA)
* Presence of any sign suggesting rapidly progressing brain disorder or brain tumor
C: Inclusion Criteria:

* Subjects (male or female) must be \> 18 years or ≤ 80 years of age, with a diagnosis of epilepsy with partial seizures, as defined in the International League Against Epilepsy (ILAE) classification of seizures; partial seizures may be simple or complex, with or without secondary tonic-clonic generalization.
* Subjects must be have been diagnosed with epilepsy for at least 2 years, and must have been unresponsive to treatment with at least two but no more than five prior antiepileptic drugs (AEDs), and at the time of study enrollment are on stable dosages of 1 or 2 standard AEDs.
* They must have had a 12 lead electrocardiogram (ECG) without clinically significant abnormal findings prior to randomization.
* Subjects must have had magnetic resonance imaging or contrast enhance computed tomography scan of the brain that demonstrated no progressive structural central nervous system abnormality at the time of the diagnosis of epilepsy.
* Women of childbearing potential must be established on an effective method of contraception during the study. Women should also have a negative pregnancy test prior to study entry.
* During the 6-week baseline period, subjects must have had a minimum of four partial seizures, with no 28 day period free of partial seizures with or without secondary generalization. A caregiver or witness must be with the subject for a sufficient duration to accurately chronicle the occurrence of seizures. These seizures must have been documented in the subject's diary.
* Subjects with electroencephalograph (EEG) testing done within 2 years of randomization. EEG abnormalities should be consistent with a diagnosis of focal-onset epilepsy.
* Signed and dated informed consent will be obtained from each subject (only include those able to consent) in accordance with the local regulatory and legal requirements.
* Subjects who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other trial procedures. Subjects who are willing, but need assistance for self administered questionnaires may be considered acceptable, but must first be discussed on a case-by-case basis with the Pfizer monitor prior to any to any screening tests or procedures for the study.

Exclusion Criteria:

* Females who are pregnant, breastfeeding, or intending to become pregnant during the course of the trial.
* Subjects with other neurologic illness that could impair endpoint assessment, or patients with Lennox-Gastaut syndrome, absence seizures, status epilepticus within the 12 months prior to study entry, or with seizures due to an underlying medical illness or metabolic syndrome.
* Subjects with clinically significant liver disease or with a calculated creatinine clearance of \<60mL/min.
* Subjects with a history of lack of response, hypersensitivity or poor tolerability to gabapentin or pregabalin.
* Previous use of gabapentin or pregabalin within 2 weeks prior to screening or likelihood of engaging in these treatments during the study period.
* Use of prohibited medications as listed in the protocol in the absence of appropriate washout phase or the likelihood of requiring treatment during the study period with drugs not permitted by the study protocol.
* Participation in any other studies involving investigational or marketed products, concomitantly or within 30 days prior to entry in the study.
* Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with trial participation or investigational product administration or may interfere with the interpretation of trial results and, in the judgment of the investigator, would make the subject inappropriate for entry into this trial.
* Subjects who are not suitable to be treated with pregabalin or gabapentin according to the respective local labeling.
* Subjects with a history of retinal abnormalities or treatment with retinotoxic agents.
D: Inclusion Criteria:

* Well-characterized focal epilepsy/epileptic syndrome according to the 1989 International League Against Epilepsy (ILAE) classification
* Presence of an EEG reading compatible with the clinical diagnosis of focal epilepsy within the last 5 years
* Presence of a brain MRI/computed tomography (CT) scan performed within the last 2 years
* Subjects having at least 8 Type I seizures \[POS; focal seizures (according to the 1981 ILAE classification)\] during the 8-week Baseline Period with at least 2 Type I seizures during each 4-week interval of the Baseline Period
* Subjects having at least 2 partial onset seizures whether or not secondarily generalized per month during the 3 months preceding V1
* Subjects being uncontrolled while treated by 1 or 2 permitted concomitant AED(s). Vagal Nerve Stimulation (VNS) is allowed and will be counted as a concomitant AED
* Permitted concomitant AED(s) and VNS being stable and at optimal dosage for the subject from at least 1 month (3 months for phenobarbital, phenytoin, and primidone) before V1 and expected to be kept stable during the Baseline and Treatment Period. Benzodiazepine taken more than once a week (for any indication) will be considered as a concomitant AED

Exclusion Criteria:

* Subject previously randomized within this study or any other prior study with BRV as a dosing arm
* Seizure type IA (1981 ILAE classification) nonmotor as only seizure type.
* Subject is currently treated with LEV or has taken LEV within 90 days prior to V1
* Subject has any medical or psychiatric condition, obvious cognitive impairment or mental retardation that, in the opinion of the Investigator, could jeopardize or would compromise the subject's ability to participate in this study
* Subjects whose seizures could not be reliably counted on a regular basis due to their fast and repetitive occurrence (clusters or flurries)
* Subject has history or presence of status epilepticus during the year preceding V1 or during Baseline
* Subject has history or presence of known psychogenic nonepileptic seizures
* Subject on felbamate with less than 18 months exposure before V1
* Subject currently on vigabatrin. Subject with history of vigabatrin use but either no visual fields examination report available including standard static (Humphrey or Octopus) or kinetic perimetry (Goldman) or results of these examinations are abnormal
* Subject taking any drug with possible central nervous system (CNS) effects except if stable from at least 1 month before V1 and expected to be kept stable during the Treatment Period
* Subject has history of cerebrovascular accident, including transient ischemic attack, in the last 6 months
* Subject is suffering from severe cardiovascular disease or peripheral vascular disease
* Subject has a lifetime history of suicide attempt or has suicidal ideation in the past 6 months
* Subject has ongoing psychiatric disease other than mild controlled disorder

Answer: A