Partial Onset Seizures | A Safety, Efficacy, and Tolerability Trial of Pregabalin as Add-On Treatment in Pediatric Subjects <4 Years of Age With Partial Onset Seizures.
Partial Onset Seizures research study
What is the primary objective of this study?
This study is designed to evaluate the effectiveness of 2 doses of pregabalin to reduce seizure frequency as an add on therapy in pediatric subjects 1 month to <4 years of age with refractory partial onset seizures. It is hypothesized that both doses of pregabalin will demonstrate superior efficacy when compared to placebo by reducing the partial onset seizure frequency and that pregabalin will be safe and well tolerated.
Who is eligible to participate?
Inclusion Criteria: - Subject must have 3 partial onset seizures in the month prior to screening. - Subject must have 2 partial onset seizures during the 48 hour baseline phase. - Signed Informed Consent. - On 1-3 stable anti-epileptic drugs at screening. Exclusion Criteria: - Primary generalized seizures including clonic, tonic, clonic-tonic, absence, febrile seizures, and infantile spasms. - Lennox-Gasteau, BECTS, and Dravet's syndrome. - Status epliepticus within 1 year of screening. - Any change in AED regimen with 7 days of screening. - Progressive structural central nervous system (CNS) lesion or a progressive encephalopathy. - Progressive errors of metabolism.
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Partial Onset Seizures
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Drug:Pregabalin Dose Level 1Pregabalin liquid dosed daily three times a day in equally divided doses escalated to 7.0 mg/kg/day beginning at Randomization through Taper Phase then tapered to 3.5 mg/kg/day during 1 week Taper Phase
Drug:Pregabalin Dose Level 2Pregabalin liquid dosed daily three times a day in equally divided doses escalated to 14.0 mg/kg/day beginning at Randomization through Taper Phase then tapered to 3.5 mg/kg/day during 1 week Taper Phase
Drug:PlaceboPlacebo Liquid dosed three times daily beginning at Randomization through Taper Phase
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
Study Drug Level 1
Study Drug Level 2
Start Date: September 2014
Completed Date: March 2018
Phase: Phase 3
Primary Outcome: Percent reduction of 24 hour seizure rate for all partial onset seizures relative to placebo during the double-blind assessment phase.
Secondary Outcome: Responder rate, defined as the proportion of subjects who had at least a 50% reduction in 24 hour partial onset seizure rate.
Study sponsors, principal investigator, and references
Principal Investigator: Pfizer CT.gov Call Center
Lead Sponsor: Pfizer