Offered by: Nemours Children's Specialty Care, Jacksonville
Location: Jacksonville, Fla.
What is the trial about?
The purpose of the study is to find out if perampanel, (also called Fycompa), helps children and youths control the frequency or severity of seizures over time, and how long most patients stay on perampanel once they begin using it.
Who can participate?
Children and youths who are at least 12 years old and have been diagnosed with Partial Onset Seizures with or without Secondarily Generalized Seizures or with Primary Generalized Tonic-Clonic Seizures.
What is involved?
Your child’s participation in the study will last about 56 weeks, a little over 1 year. There is a screening period (up to 6 weeks) where your child will come into the clinic for an initial visit; a 13-week dose adjustment period where follow up phone calls will be made about every 2 weeks between Week 4 and Week 13 and your child’s perampanel dose may be adjusted; a 39-week maintenance period where your child will come into the clinic for 3 study appointments during that time; and lastly a 4-week follow up period with a final clinic visit at the end of the study.
There are 1 - 2 blood draws (the 2nd one is optional), 6 visits where we will obtain vital signs (heart rate, respiratory rate, blood pressure, weight and height), and about 6 visits where we will have your child complete study questionnaires. You or your child will keep a seizure diary throughout the entire study period.
Contact Nemours Clinical Trials
Trial Name: Open Label Sudy to Evaluate the Efficacy & Safety of Perampanel in Treatment of Seizures