Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Double-blind, Placebo-controlled, Parallel-group, Multicenter Study Of The Efficacy And Safety Of Pregabalin As Adjunctive Therapy In Children 1 Month Through <4 Years Of Age With Partial Onset Seizures
Brief Summary: This study is designed to evaluate the effectiveness of 2 doses of pregabalin to reduce seizure frequency as an add on therapy in pediatric subjects 1 month to \<4 years of age with refractory partial onset seizures. It is hypothesized that both doses of pregabalin will demonstrate superior efficacy when compared to placebo by reducing the partial onset seizure frequency and that pregabalin will be safe and well tolerated.


Options:
A: 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.
B: Inclusion Criteria:

* Subjects (male or female) must be \> 18 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.

Exclusion Criteria:

* Females who are pregnant, breastfeeding, or intend to become pregnant during the course of the trial will be excluded
* Subjects with other neurologic illness that could impair endpoint assessment, or subjects with Lennox-Gastaut syndrome, absence seizures, status epileptics within the 12 months prior to trial entry, or with seizures due to an underlying medical illness or metabolic syndrome, will be excluded.
C: Inclusion Criteria:

* Well-characterized focal epilepsy or epileptic syndrome according to the International League Against Epilepsy (ILAE) classification
* Subjects with a history of partial onset seizures
* Subjects having at least 4 partial onset seizures during the Baseline period and at least 2 partial onset seizures per month during the 3 months preceding Visit 1
* Subjects being uncontrolled while treated by 1 or 2 concomitant Antiepileptic drug(s) AED(s) being stable
* Male/ female subjects from 16 to 65 years, both inclusive. Subjects under 18 years may only be included where legally permitted and ethically accepted

Exclusion Criteria:

* Seizure type IA non-motor as only seizure type
* History or presence of seizures occurring only in clustered patterns
* History of cerebrovascular accident (CVA)
* Presence of any sign suggesting rapidly progressing brain disorder or brain tumor
D: Inclusion Criteria:

* Subject must have 3 partial onset seizures in the month prior to screening.
* Subject must have 2 partial onset seizures during the 48 hour baseline phase.
* Signed Informed Consent.
* On 1-3 stable anti-epileptic drugs at screening.

Exclusion Criteria:

* Primary generalized seizures including clonic, tonic, clonic-tonic, absence, febrile seizures, and infantile spasms.
* Lennox-Gasteau, BECTS, and Dravet's syndrome.
* Status epliepticus within 1 year of screening.
* Any change in AED regimen with 7 days of screening.
* Progressive structural central nervous system (CNS) lesion or a progressive encephalopathy.
* Progressive errors of metabolism.

Answer: D