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4. An Open-Label, Multicenter study with an Extension Phase to Evaluate the Safety , Tolerability, and Exposure-Efficacy Relationship of Perampanel Oral suspension when Administered as an Adjunctive Therapy in pediatric Subjects (Age 4 to less than 12years) with inadequately Controlled Partial-Onset Seizures or Primary generalized Tonic-Clonic seizures

Protocol: E2007-311

PI: Eric Segal, MD

Sponsor: Eisai

Key Inclusion Criteria:

* Have a diagnosis of epilepsy with POS with or without secondary generalization or PGTC according to the International League Against Epilepsy's (ILAE) Classification of Epileptic Seizures (1981). Diagnosis should have been established at least 6 months prior to Visit 1 by clinical history and an EEG that is consistent with the diagnosis

* Male or female subject, from age 4 to less than 12 years at the time of informed consent/ assent 

* Are currently being treated with stable doses of  1 to a maximum of 2 approved AEDs. Doses must be stable for at least 4 weeks before to Visit 1; in the case where a new AED regimen has been initiated for a subject, the dose must be stable for at least 8 weeks prior to Visit 1. Only 1 EIAED (defined as carbamazepine, phenytoin, oxcarbazepine)  out of the maximum of 2 AEDs is allowed (A vegul nerve stimulator [VNS] will be counted as one of the 2 allowed AEDs).

Exclusion Criteria:

* Current or history of pseudo-seizures (psychogenic nonepileptic seizures) within approximately 5 years before Visit 1.

* Have a history of status epilepticus that required hospitalization during the 6 months before Visit 1.

* Are scheduled and / or confirmed to have epilepsy surgery within 6 months after Visit 1; however, those who have previously documented "failed" epilepsy surgery will be allowed.

* Evidence of clinically significant disease (eg, cardiac, respiratory, gastrointestinal, renal disease that in the opinion of the investigator(s) should affect the subject's safety or interfere with the study assessments.

* Sever renal insufficiency.

 

 



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