Status:
TERMINATED
Study in Pediatric Subjects With Epilepsy
Lead Sponsor:
GlaxoSmithKline
Collaborating Sponsors:
Bausch Health Americas, Inc.
Conditions:
Epilepsy
Eligibility:
All Genders
12-17 years
Phase:
PHASE2
Brief 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 o...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 25 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 29 2013
Estimated Enrollment :
5 Patients enrolled
Trial Details
Trial ID
NCT01494584
Start Date
July 25 2012
End Date
April 29 2013
Last Update
November 30 2020
Active Locations (4)
Enter a location and click search to find clinical trials sorted by distance.
1
GSK Investigational Site
Los Angeles, California, United States, 90027
2
GSK Investigational Site
Wellington, Florida, United States, 33414
3
GSK Investigational Site
Memphis, Tennessee, United States, 38105
4
GSK Investigational Site
Dallas, Texas, United States, 75230-2507