Study in Pediatric Subjects With Epilepsy

Open-label, Multiple Dose Study to Evaluate the Parmacokinetics, Safety and Tolerability of Ezogabine/Retigabine as Adjunctive Treatment in Subjects Aged From 12 Years to Less Than 18 Years With Partial Onset Seizures or Lennox-Gastaut Syndrome

This is an open-label study to evaluate the pharmacokinetics, safety and tolerability of ezogabine/retigabine in subjects aged 12 years to less than 18 years with uncontrolled partial onset seizures or Lennos-Gastaut syndrome.

Inclusion Criteria:

• Between 12 and 18 years of age.
• Diagnosis of uncontrolled partial onset seizures (with or without secondarily generalized seizures) or Lennox-Gastaut syndrome.
• Taking between one and three antiepileptic drugs.
• Able to swallow tablets.
• Females must be of : (1) Non-childbearing potential or (2) Child-bearing potential and agrees to use acceptable contraception.

Exclusion Criteria:

• Epilepsy secondary to progressive cerebral disease, tumor or any progressive neurodegenerative disease.
• History of status epilepticus in the last six months.
• Currently treated with felbamate or has been treated with vigabatrin within the past 6 months.
• Following the ketogenic diet.
• Suicidal intent or history of suicide attempt in the last 2 years.
• Elevated liver enzymes or abnormal kidney function.
• Current disturbance of micturition or known urinary obstructions.
• History of vesicoureteric reflux.
• Abnormal post-void residual bladder ultrasound.
• Urinary retention and/or required urinary catheterization in the preceding 6 months.
• Abnormal urine sample at screening/.baseline.
• Abnormal blood sample at screening.
• Clinically significant arrhythmias.
• Abnormal ECG at screening.
• BMI lower than the 10th percentile for age and gender or subject weighs less than 30kg.