Study in Pediatric Subjects With Epilepsy

GlaxoSmithKline (GSK)

Status and phase

Terminated

Phase 2

Conditions

Epilepsy

Treatments

Drug: ezogabine/retigabine

Study type

Interventional

Funder types

Industry

Identifiers

NCT01494584

113284

Details and patient eligibility

About

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.

Enrollment

5 patients

Sex

All

Ages

12 to 17 years old

Volunteers

No Healthy Volunteers

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.