Have any questions? 706-721-6582 or cts@augusta.edu
- (NO1269 Absence) Randomized, Dose-Finding and Confirmatory, Double-Blind, Placebo-Controlled, Parallel Group Multicenter Study with a 2-Stage Adaptive Design and Randomized Withdrawal to Evaluate the Efficacy, Safety, and Tolerability of Brivaracetam as Monotherapy in Patients 2 to 25 Years of Age with Childhood Absence Epilepsy or Juvenile Absence Epilepsy
Clinical Trial
(NO1269 Absence) Randomized, Dose-Finding and Confirmatory, Double-Blind, Placebo-Controlled, Parallel Group Multicenter Study with a 2-Stage Adaptive Design and Randomized Withdrawal to Evaluate the Efficacy, Safety, and Tolerability of Brivaracetam as Monotherapy in Patients 2 to 25 Years of Age with Childhood Absence Epilepsy or Juvenile Absence Epilepsy
This study will investigate the efficacy of brivaracetam monotherapy in patients 2 to 25 years of age inclusive, diagnosed with childhood or juvenile absence epilepsy. The study will last about 5 months. Subjects may take a placebo during two 2-week periods, and will take brivaracetam during the rest of the 5 months. There will be 13 clinic visits. After the 5 months, subjects may be eligible to participate in a long-term folllow-up study and continue taking brivaracetam.
Eligibility Criteria
- Subjects must be 2 to 25 years of age, weight >20 lbs, with either childhood or juvenile absence seizures, and must not currently be taking any seizure medications. Subjects should be otherwise healthy with no major psychiatric or medical condition that would affect study participation.
RESEARCH. INNOVATION. DISCOVERY.