Pregabalin adjunctive therapy for focal onset seizures in children 1 month to <4 years of age: A double‐blind, placebo‐controlled, video‐electroencephalographic trial
- 18 March 2020
- Vol. 61 (4), 617-626
- https://doi.org/10.1111/epi.16466
Abstract
Objective To evaluate the efficacy and safety of pregabalin as adjunctive treatment for children (aged 1 month‐e[24‐hour seizure rate + 1]) for all FOS recorded during the double‐blind V‐EEG monitoring, evaluated in subjects who took ≥1 dose of study medication, experienced ≥1 baseline seizure(s), and had a treatment phase V‐EEG. Safety and tolerability were assessed by adverse events (AEs), clinical laboratory data, physical/neurological examinations, vital signs, and electrocardiograms. Results Overall, 175 patients were randomized (mean age = 28.2 months; 59% male, 69% white, 30% Asian) in a 2:1:2 ratio to pregabalin 7 or 14 mg/kg/d (n = 71 or n = 34, respectively), or placebo (n = 70). Pregabalin 14 mg/kg/d (n = 28) resulted in a statistically significant 35% reduction of loge(24‐hour seizure rate + 1) versus placebo (n = 53; P = .022), an effect that was not observed with pregabalin 7 mg/kg/d (n = 59; P = .461). The most frequently reported treatment‐emergent AEs for pregabalin 7 mg/kg/d, 14 mg/kg/d, and placebo, respectively, were somnolence (11.3%, 17.6%, and 5.7%) and upper respiratory tract infection (7.0%, 11.8%, and 11.4%). All AEs were mild to moderate in severity. Significance Pregabalin 14 mg/kg/d (but not 7 mg/kg/d) significantly reduced seizure rate in children with FOS, when assessed using V‐EEG, compared with placebo. Both pregabalin dosages were generally safe and well tolerated in children 1 month to <4 years of age with FOS. Safety and tolerability were consistent with the known profile of pregabalin in older children with epilepsy.Keywords
Funding Information
- Pfizer
This publication has 18 references indexed in Scilit:
- Pregabalin as Adjunctive Treatment for Focal Onset Seizures in Pediatric Patients: A Randomized Controlled TrialJournal of Child Neurology, 2019
- Antiepileptic Drug Treatment in Children with EpilepsyCNS Drugs, 2015
- Safety, tolerability, and pharmacokinetics of pregabalin in children with refractory partial seizures: A phase 1, randomized controlled studyEpilepsia, 2014
- Pharmacotherapy of Focal Epilepsy in Children: A Systematic Review of Approved AgentsCNS Drugs, 2013
- Seizure diaries for clinical research and practice: Limitations and future prospectsEpilepsy & Behavior, 2012
- Revised terminology and concepts for organization of seizures and epilepsies: Report of the ILAE Commission on Classification and Terminology, 2005–2009Epilepsia, 2010
- Usefulness of Video-EEG MonitoringEpilepsia, 2006
- Use of New Antiepileptic Drugs in the Treatment of Childhood EpilepsyEpilepsia, 1999
- If a first antiepileptic drug fails to control a child's epilepsy, what are the chances of success with the next drug?The Journal of Pediatrics, 1997
- Recognition and Classification of Seizures in InfantsEpilepsia, 1997