Long-term, Open-label Safety Extension Study of Retigabine/Ezogabine in Pediatric Subjects (>= 12 Years Old) With POS or LGS

• Incidence of adverse events [ Time Frame: up to 6 years ] [ Designated as safety issue: No ]
  number and percent of subjects with at least one
  
  
• Incidence of serious adverse events (SAEs) [ Time Frame: up to 6 years ] [ Designated as safety issue: No ]
  number and percent of subjects with at least one
  
  
• Incidence of AEs leading to withdrawal [ Time Frame: up to 6 years ] [ Designated as safety issue: No ]
  number and percent of subjects with at least one
  
  
• Incidence of vital signs outside normal ranges and pre-determined clinically important findings [ Time Frame: up to 6 years ] [ Designated as safety issue: No ]
  number and percent of subjects with at least one
  
  
• Summary and change from baseline in vital signs, height, weight, and body mass index [ Time Frame: up to 6 years ] [ Designated as safety issue: No ]
  means, medians, minimum, maximum, estimations of variance
  
  
• Summary and change from baseline of ECG parameters [ Time Frame: up to 6 years ] [ Designated as safety issue: No ]
  means, medians, minimum, maximum, estimations of variance
  
  
• Summary of ECG assessment and interpretation of clinical significance based on investigator judgment [ Time Frame: up to 6 years ] [ Designated as safety issue: No ]
  number and percent of subjects by category (not abnormal; abnormal, not clinically significant; abnormal, clinically significant
  
  
• Changes from baseline in hematology, chemistry, and urinalysis parameters [ Time Frame: up to 6 years ] [ Designated as safety issue: No ]
  means, medians, minimum, maximum, estimations of variance
  
  
• Incidence of hematology, chemistry and urinalysis parameters outside normal ranges and pre-determined clinically important ranges [ Time Frame: up to 6 years ] [ Designated as safety issue: No ]
  number and percent of subjects with at least one
  
  
• Changes from baseline in bladder volume as assessed by the post-void residual ultrasound [ Time Frame: up to 6 years ] [ Designated as safety issue: No ]
  means, medians, minimum, maximum, estimations of variance
  
  
• Changes from baseline in cognition, behavior and learning, as measured by the Leiter-R, Child Behavior Checklist, and Wide Range Assessment of Memory and Learning 2nd Edition, respectively [ Time Frame: up to 6 years ] [ Designated as safety issue: No ]
  means, medians, minimum, maximum, estimations of variance by domain
  
  
• Summary of sexual maturation over time based on the Tanner Stages of Puberty in subjects <= 18 years old [ Time Frame: up to 6 years ] [ Designated as safety issue: No ]
  number and percent of subjects by stage
  
  
• Time to withdrawal [ Time Frame: up to 6 years ] [ Designated as safety issue: No ]
  means, medians, minimum, maximum, estimations of variance
  
  

• percent change from baseline in seizure frequency [ Time Frame: up to 6 years ] [ Designated as safety issue: No ]
  baseline from the "parent" study; means, medians, minimum, maximum, estimations of variance
  
  
• percentage of responders [ Time Frame: up to 6 years ] [ Designated as safety issue: No ]
  >=50% reduction from baseline ("parent" study) in seizure frequency
  
  
• clinical global impression of severity (CGI-S) [ Time Frame: up to 6 years ] [ Designated as safety issue: No ]
  means, medians, minimum, maximimum, estimations of variance
  
  
• clinical global impression of improvement (CGI-I) [ Time Frame: up to 6 years ] [ Designated as safety issue: No ]
  means, medians, minimum, maximimum, estimations of variance
  
  
• summary of change from baseline in child health status (Child Health Questionnaire in subjects < 18 years old) [ Time Frame: up to 6 years ] [ Designated as safety issue: No ]
  means, medians, minimum, maximimum, estimations of variance
  
  
• summary of pharmacokinetic AUC [ Time Frame: up to 6 years ] [ Designated as safety issue: No ]
  means, medians, minimum, maximimum, estimations of variance
  
  
• summary of pharmacokinetic Cl/F [ Time Frame: up to 6 years ] [ Designated as safety issue: No ]
  means, medians, minimum, maximimum
  
  

Epilepsy is among the most common serious neurologic disorders in childhood. Medicines with novel actions of mechanisms of action are needed to try to address the unmet clinical need for seizure control in patients with treatment-resistant epilepsy. The purpose of this study is to evaluate the long-term safety and tolerability of retigabine/ezogabine as an adjunctive treatment in subjects with either partial onset seizures (12 to < 18 years old) or Lennox-Gastaut Syndrome (12 to <30 years old) who have participated in a previous ("parent") study.