Study in Pediatric Subjects With Epilepsy

• Status: Terminated
• Trial end date: 2013-04-29
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: GlaxoSmithKline
• Collaborators: Bausch Health Americas, Inc.; Valeant Pharmaceuticals International, Inc.
• Treatments: Ezogabine

Criteria

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.