Clinical trial NCT00144690 (phase 2, status: completed)
Conditions: epilepsy
ICD codes: G40.803, G40.804, G40.911, G40.919, G40.B11, G40.B19, G40.801
Drugs: e2007 (perampanel), placebo
SMILES: O=C1N(C=C(C=C1C1=CC=CC=C1C#N)C1=NC=CC=C1)C1=CC=CC=C1, CN1C(=O)C=C(N2CCC[C@@H](N)C2)N(CC2=C(C=CC=C2)C#N)C1=O
Eligibility criteria:

        Inclusion Criteria:

          -  Provide written informed consent signed by patient or legal guardian prior to entering
             the study or undergoing any study procedures.

          -  Are reliable and willing to make themselves available for the study period and are
             able to record seizures and report adverse events themselves or have a caregiver who
             can record and report the events.

          -  Male and female patients will be eligible for enrollment. Females should be either of
             non-childbearing potential as a result of surgery, radiational therapy, menopause (one
             year post onset), or of childbearing potential and practicing a medically acceptable
             method of contraception (eg, abstinence, a barrier method plus spermicide, or
             intrauterine device [IUD]) for at least three months before Visit 1 (Screening) and
             for two months after the end of the study. They must also have a negative serum
             beta-human chorionic gonadotropin (beta-hCG) at Screening. Pregnant and/or lactating
             females are excluded. Those women using an oral contraceptive must also be using an
             additional approved method of contraception (eg, a barrier method plus spermicide, or
             IUD) starting with the Baseline Phase and continuing throughout the entire study
             period.

          -  Are between the ages of 18 and 70 years of age, inclusive.

          -  Are of 40 kg (88 lb) of weight or more.

          -  Have the diagnosis of epilepsy with partial-onset seizures with or without secondarily
             generalized seizures according to the International League Against Epilepsy's
             Classification of Epileptic Seizures (1981). Diagnosis should have been established by
             clinical history, electroencephalogram (EEG) and computed tomography/magnetic
             resonance imaging (CT/MRI) of the brain performed within the last 10 years and
             consistent with localization-related epilepsy.

          -  Have uncontrolled partial seizures despite having been treated with at least three
             different anti-epileptic drugs (AEDs) (given concurrently or sequentially) for at
             least 2 years.

          -  To be enrolled, patient must have averaged at least 4 partial seizures per month, with
             no 21-day seizure-free period during the 2 months preceding randomization. To be
             randomized, the patient must have had at least 3 seizures during the prospective
             Baseline Phase (28 days), with no 21-day seizure-free period. This should be
             documented in the form of medical history, medical records, or photocopied records of
             the patient diary/patient chart. Simple partial seizures without motor signs will not
             be counted towards this inclusion criterion.

          -  Are currently being treated with one or a maximum of two licensed AEDs and are known
             to take their medication(s) as directed.

          -  Are on a stable dose(s) of the same AED(s) for the 2 months prior to Visit 1.

          -  If using a vagal nerve stimulator, it must have been implanted for at least 5 months
             prior to Visit 1. Stimulator parameters may not be changed for at least 1 month prior
             to Visit 1 or thereafter during the study. Magnet use will be allowed and documented
             throughout the study.

        Exclusion Criteria:

          -  Have participated in a study involving administration of an investigational compound
             within one month of Visit 1 (Screening), or within 5 half-lives of the previous
             investigational compound, whichever is longer.

          -  Presence of non-motor simple partial seizures only.

          -  Presence of primary generalized epilepsies or seizures, such as absences, myoclonic
             epilepsies, Lennox-Gastaut syndrome.

          -  History of status epilepticus in the past year or seizure clusters where individual
             seizures cannot be counted.

          -  Show evidence of clinically significant disease (cardiac, respiratory,
             gastrointestinal, renal disease, etc) that in the opinion of the Investigator(s) could
             affect the patient's safety or trial conduct.

          -  Show evidence of significant active hepatic disease. Stable elevations of liver
             enzymes, alanine aminotransferase (ALT), and aspartate aminotransferase (AST) due to
             concomitant medication(s) will be allowed if they are less than 2 times the upper
             limit of normal (ULN).

          -  Show evidence of significant active hematological disease. White blood cell (WBC)
             count cannot be <= 2500/µL or an absolute neutrophil count <= 1000/µL.

          -  Clinically significant electrocardiogram (ECG) abnormality, including prolonged QTc
             defined as >= 450 msec for males and >= 470 msec for females.

          -  Presence of major active psychiatric disease. Patients taking a stable dose of
             selective serotonin reuptake inhibitor (SSRI) antidepressant will be allowed (except
             fluvoxamine).

          -  Presence of a progressive central nervous system (CNS) disease, including degenerative
             CNS diseases and tumors.

          -  Have a history of psychogenic seizures.

          -  Have a history of drug abuse and/or positive finding on urinary drug screening, other
             than prescribed medication.

          -  Have a history of alcohol abuse in the past 2 years, and/or positive finding on
             urinary drug screen.

          -  Have had multiple drug allergies (dermatological, hematological or organ toxicity) or
             one or more severe drug reactions.

          -  Allergy to lactose.

          -  Concomitant use of felbamate or use of felbamate within 2 months prior to Visit 1.

          -  Concomitant use of vigabatrin. Patients that took vigabatrin in the past must be off
             vigabatrin for at least 5 months prior to Visit 1 and must not have evidence of a
             clinically significant abnormality in a visual perimetry test.

          -  Concomitant use or use within the previous 4 weeks prior to Visit 1 of neuroleptics,
             monoamine oxidase (MAO) inhibitors, barbiturates (except for seizure control
             indication), benzodiazepines (other than occasional intermittent use), and narcotic
             analgesics.

          -  Frequent need of rescue benzodiazepines (one or more times a month).