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 12 years) with Inadequately Controlled Partial-Onset Seizures or Primary Generalized Tonic-Clonic Seizures

What we are studying

This research study is being done to investigate whether perampanel is safe and effective at helping control seizures in children who are between the ages of 4 and 12 and are already taking seizure medications. The study will also look at how much perampanel gets into the blood stream 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
  • Ages 4 - 12

Eligibility Criteria

  • Inclusion criteria:
    • 1. Male or female
  • From 4 to less than 12 years of age at the time of consent 2. Have a minimum weight of 16 kg (35 lb) 3. Have a diagnosis of epilepsy with Partial-Onset Seizures with or without secondarily generalized seizures or Primary Generalized Tonic-Clonic seizures 4. Currently being treated with a stable dose (ie
  • Unchanged for at least 4 weeks) of 1 to a maximum of 2 AEDs Exclusion criteria:
    • 1. Have a history of status epilepticus that required hospitalization during the 6 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

What is involved

  • You can expect your child to be in this study for up to 56 weeks / 14 months. This study consists of 2 parts: the Core Study (Visits 1-9) and the Extension Study (Visits 10-12). The Core study can last up to 27 weeks. If your child completes the Core Study and the study doctor finds your child eligible
  • He/She may enter the Extension Study if you agree. The Extension Study can last up to 33 weeks.

Compensation

$50 per completed visit

Contact Information

Study Coordinator
Jessica Dimos
Email
[email protected]
Phone
-8694
Principal Investigator
Gautam Popli, MD

Disclaimer: The information on this website is for general informational purposes only and SHOULD NOT be relied upon as a substitute for sound professional medical advice, evaluation or care from your physician or other qualified health care provider.