A Study With an Open-label Extension Phase to Evaluate the Effect of Perampanel (E2007) on Cognition, Growth, Safety, Tolerability, and Pharmacokinetics in Adolescents
Condition: Epilepsy
MeSH terms: Epilepsy
Intervention: Perampanel; Placebo
Intervention description: 2 mg titrated up to 8-12 mg maximum; taken once daily.; Matching Placebo taken once daily.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 133.0
Sex: All
Minimum age: 12 Years
Maximum age: 18 Years
Healthy volunteers: No

Summary:

      This study is designed to investigate the short- and long-term effects of perampanel on
      cognition, growth, and development in adolescents.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Considered reliable and willing to be available for the study duration and was able to
             record seizures and report adverse events (AEs) themselves or had a legal guardian or
             a caregiver who could record seizures and report AEs for them.

          2. Understand the requirements of the Cognitive Drug Research (CDR) System tests and able
             to perform the tests appropriately at Visit 1.

          3. Male or female, 12 to less than 18 years of age at the time of consent/assent

          4. Had a diagnosis of epilepsy with partial-onset seizures with or without secondarily
             generalized seizures according to the International League Against Epilepsy's (ILAE)
             Classification of Epileptic Seizures (1981).

          5. Diagnosis was established at least 6 months prior to Visit 1, by clinical history and
             an electroencephalogram (EEG) that was consistent with localization-related epilepsy;
             normal interictal EEGs were allowed provided that the subject met the other diagnosis
             criterion (ie, clinical history).

          6. Had a brain imaging (e.g., magnetic resonance imaging [MRI] scan or computed
             tomography [CT]) within the 5 years prior to Visit 1 that ruled out a progressive
             cause of epilepsy.

          7. Had at least 1 partial-onset seizure during the 4 weeks prior to Visit 1 despite a
             stable regimen of 1 to 3 concomitant antiepileptic drugs (AEDs).

          8. Were currently being treated with stable doses of 1-3 AEDs. Only 1 inducer AED (either
             carbamazepine or phenytoin) out of the maximum of 3 AEDs was allowed.

          9. Were on a stable dose of the same concomitant AED(s) for at least 4 weeks prior to
             Visit 1; in the case where a new AED regimen was initiated for a subject, the dose
             must have been stable for at least 8 weeks prior to Visit 1.

         10. Female subjects of childbearing potential must had a negative serum human chorionic
             gonadotropin (beta-hCG) at Visit 1 and a negative urine pregnancy test prior to
             randomization at Visit 2. Female subjects of period of at least 60 days following
             administration of the last dose of study medication to commit to the consistent and
             correct use of a medically acceptable method of birth control (e.g., a double-barrier
             method [condom + spermicide, condom + diaphragm with spermicide]). Abstinence was
             considered an acceptable method of contraception on a case by case basis upon prior
             approval by the Medical Monitor.

         11. Had an intelligence quotient (IQ) of greater than or equal to 70, using the Kaufman
             Brief Intelligence Test, second edition (KBIT-2).

         12. Provided written informed consent signed by the legal guardian and a written assent
             from the subject prior to entering the study or undergoing any study procedures.

        Extension Phase:

        Had completed all scheduled visits up to and including Visit 8 in the Core Study
        Randomization Phase.

        Exclusion Criteria:

          1. Had a diagnosis of primary generalized epilepsies or seizures such as absences and/or
             myoclonic epilepsies.

          2. Had current or a history of pseudo-seizures (psychogenic non-epileptic seizures
             [PNES]) within approximately 5 years prior to Visit 1.

          3. Had a diagnosis of Lennox-Gastaut syndrome.

          4. Had seizure clusters where individual seizures could not be counted.

          5. Had a history of status epilepticus that required hospitalization during the 12 months
             prior to the Visit 1.

          6. Had an unstable psychiatric diagnosis that could confound the investigator's ability
             to conduct the study or that could prevent completion of the protocol specified tests
             (e.g., significant suicide risk, including suicidal behavior and ideation 6 months
             prior to Visit 1, current psychotic disorder, or acute mania).

          7. Had any concomitant illnesses/co-morbidities (e.g., autism, attention deficit
             hyperactivity disorder [ADHD]) at Visit 1 that could severely affect cognitive
             function during the course of the study.

          8. Had previously participated in a clinical trial involving perampanel.

          9. Had chronically or routinely use benzodiazepines and who have not discontinued the use
             at least 4 weeks prior to Visit 1.