Study in Pediatric Subjects With Epilepsy
| Status: | Terminated |
|---|---|
| Conditions: | Neurology, Epilepsy |
| Therapuetic Areas: | Neurology, Other |
| Healthy: | No |
| Age Range: | 12 - 17 |
| Updated: | 6/22/2018 |
| Start Date: | July 25, 2012 |
| End Date: | April 29, 2013 |
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.
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.
We found this trial at
9
sites
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