#Pichon ave trial

Six (12.8%) patients reported serious TEAEs, most commonly status epilepticus (3/47 6.4%). Twenty (42.6%) patients discontinued due to TEAEs, most commonly vomiting (8.5%), gait disturbance, dizziness, and somnolence (6.4% each). The most common TEAEs (≥10% of patients) were vomiting (21.3%), diarrhea (14.9%), somnolence (12.8%), irritability, dizziness, and pyrexia (10.6% each). Treatment-emergent adverse events (TEAEs) were reported by 42/47 (89.4%) patients.

#Pichon ave trial

24/47 (51.1%) patients completed the trial at the maximum cohort-defined dose and 40/47 (85.1%) continued lacosamide in the extension trial. Patients who did not achieve the maximum cohort-defined dose were discontinued.įorty-seven patients (aged 6 months-≤17 years) enrolled (≥1 month-<4 years: n = 15 ≥4-<12 years: n = 23 ≥12-≤17 years: n = 9). Oral lacosamide was initiated at 2 mg/kg/day (1 mg/kg bid) and uptitrated by 2 mg/kg/day/week to the maximum cohort-defined dose (maximum trial duration: 13 weeks). Findings from Cohort 1, aged 5-11 years, who received lacosamide ≤8 mg/kg/day, informed dosing for age-based cohorts 2-5, who then received ≤12 mg/kg/day (≤600 mg/day). Patients were eligible for this open-label, fixed-titration trial (SP0847 NCT00938431) if aged 1 month-17 years with focal seizures taking 1-3 antiepileptic drugs. Electronic address: evaluate safety and tolerability of adjunctive lacosamide in children with focal seizures. Electronic address: 7 UCB Pharma, 8010 Arco Corporate Drive, Raleigh, NC 27617, USA. Electronic address: 6 UCB Pharma, 8010 Arco Corporate Drive, Raleigh, NC 27617, USA. Electronic address: 5 UCB Pharma, Allée de la RecherBrussels, Belgium Heilig Hart Hospitaal, MechelsestrLier, Belgium. Electronic address: 4 UCB Pharma, 8010 Arco Corporate Drive, Raleigh, NC 27617, USA. Electronic address: 3 Children's Mercy Hospital, Division of Neurology, 2401 Gillham Rd, Kansas City, MO 64108, USA. Electronic address: 2 Children's Mercy Hospital, Division of Neurology, 2401 Gillham Rd, Kansas City, MO 64108, USA. Habana Ave, Suite 340, Tampa, FL 33609, USA. Joseph's Children's Hospital, Pediatric Epilepsy and Neurology Specialists (PENS), 508 S.

1 University of South Florida, Morsani College of Medicine, Division of Child Neurology, St.