Study Information for: "An Open-Label Study to Evaluate Perampanel (E2007) Oral Suspension When Given as an Adjunctive Therapy in Subjects From 1 Month to Less Than 24 Months (<2 years) of Age With Epilepsy" - Be Involved

What we are studying

This research study is being done to see if the investigational drug, Perampanel (E2007) (called, “Study Drug”) is safe, tolerable, and can help control seizure in children with epilepsy who are 1 month to less than 24 months of age and who are already taking seizure medications. The goal of this study is to determine the concentration of the study drug in your child’s blood over a period of time.

Who is Eligible

Genders:
- Men
- Women
Races:
- White
- African American
- Asian
- American Indian or Alaska Native
- Native Hawaiian or Pacific Islander
- Other
All Ethnicities
All Ages up to 0

Eligibility Criteria

Inclusion criteria:
- 1. Male or female
From 1 to less than 24 months (<2 years) of age (and of at least 41 weeks gestational age) at the time of consent 2. Have a minimum weight of 4 kg (8.8 lb) 3. Have a diagnosis of epilepsy with any type of seizure 4. Currently being treated with a stable dose (ie
Unchanged for at least 5 half-lives) of 1 to a maximum of 3 AEDs Exclusion criteria:
- 1. Have a history of status epilepticus that required hospitalization during the 3 months before screening 2. Have seizures due to treatable medical conditions
Such as those arising due to metabolic disturbances
Toxic exposure
Or an active infection 3. Have epilepsy secondary to progressive central nervous system (CNS) disease or any other progressive neurodegenerative disease
Including tumors 4. Have had or is scheduled to have epilepsy surgery

What is involved

The study consists of two main parts that are different depending on the antiepileptic medication (AEDs) your child is currently taking: • If your child is taking any of the following enzyme-inducing AEDs (ie
Eiaeds; carbamazepine [CBZ]
Oxcarbazepine [OXC]
Phenytoin [PHT]
Or eslicarbazepine [ESL]) he/she will follow the procedures for a child using enzyme-inducing AEDs (EIAED). • If your child is NOT taking any of the enzyme-inducing AED (EIAED)
He/She will follow the procedures for a child NOT using enzyme-inducing AEDs (non-EIAED). • Part 1: The Core Phase is made up of 8 visits over 18 weeks if your child is not using EIAEDs or 9 visits over 22 weeks if your child is using EIAEDs
And • Part 2: The Extension Phase immediately follows the Core Phase and is made up of 3 visits over 40 weeks if your child is not using EIAEDs or 3 visits over 36 weeks if your child is using EIAEDs In addition
There is a Follow-Up Period that will take place at the end of the Extension Phase. The follow up period will also take place at the end of the Core Phase if your child does not participate in the Extension Phase or discontinues early from the Core Phase. The Follow-up Period lasts for up to 4 weeks. The Follow-up Visit will occur approximately 4 weeks following the last dose of study medication. Most visits to the study doctor’s office will take approximately 1-2 hours.