Perampanel Study for Infants with Epilepsy

Study Title
An Open-Label Study With an Extension Phase to Evaluate the Pharmacokinetics of 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

What is this study about? 

This clinical research study is being done to learn more about the safety of Perampanel (E2007), the study drug and how well it’s tolerated in infants, from 1 month to less than 24 months old (<2 years), who have epilepsy. Subject needs to be taking at least 1 (up to 3) seizure medicines. The study will also help determine the concentration or amount of the drug in your child’s blood over time.

Perampanel is already approved by the FDA for treatment of seizures in children (4 years of age and older), adolescents, and adults with epilepsy.

Who is eligible to join the study?

  • Children 1 month to less than 2 years of age
  • Have a diagnosis of epilepsy with any type of seizure 
  • Have had 1 or more seizure(s) recently
  • Currently taking 1 to 3 anti-epilepsy drugs (AEDs) with no changes in dosage for at least 2 weeks (if 6 months of age or younger) or 4 weeks ( if more than 6 months of age)

Study Summary 

The number of healthcare provider visits will vary depending on the seizure medication(s) your child is currently taking: 
  • If your child is taking an enzyme-inducing AED (EIAED), an AED that makes a substance in your body called an enzyme to remove perampanel from your body faster, your child will follow the study schedule for children using EIAED. Examples of EIAEDs include carbamazepine, phenytoin, oxcarbazepine, eslicarbazepine, etc. 
  • If your child is NOT taking any of the EIAEDs, they will follow the study schedule for children NOT using enzyme-inducing AED (non-EIAED).

The study consists of two main parts 

  • Part 1: Pre-dosing phase and dosing phase
  • Part 2: Extension phase, consisting of maintenance and follow up
The Pre-Dosing Phase begins with a 2-week period to see if this study is appropriate for your child.
 
The Dosing Phase: If the study is appropriate for them, your child will begin the treatment period of the study. The dose of perampanel will start at 0.5 mg/day and will slowly be increased to 12 mg/day (non-EIAED) or 16 mg/day (EIAED) over 12 to 16 weeks. The increase in perampanel dose is based on how well your child tolerates and responds to perampanel treatment and will be determined by your study doctor.
  • Children who are not taking an EIAED drug will be seen 7 times over 16 weeks.
  • Children taking an EIAED drug will be seen 8 times over 22 weeks. 
  • If your child completes the study at the end of the dosing phase (i.e., does not go into the extension phase), then your child will return to the study center 4 weeks after the last perampanel dose for a follow-up visit (last study visit).
The Extension Phase: This phase is a chance for each child to continue on the perampanel for a longer period of time. Your child will initially continue on the same dose from the end of the dosing phase.
  • Children who are not taking an EIAED will be seen 3 times over 36 weeks. 
  • Children who are taking an EIAED will be seen 3 times over 32 weeks. 
  • All children will return to the study center 4 weeks after the last perampanel dose for a final follow-up visit.

What does participation look like? 

Visits with a healthcare provder will take place during the study. Some or all of the following tests and procedures will be done: medical history, seizure diary review, medication review, physical examination, neurological examination, vital signs and weight, height/length, head circumference, electrocardiograpm (heart rhythm test), and blood samples.

The maximum total duration of treatment for each child will be 58 weeks (52 weeks treatment, 2 weeks pretreatment, and 4 week follow up), unless your childs participation ends sooner.

To learn more about this study, please use the appropriate follow-up contact below based on your geographical region: