Study in Pediatric Subjects With Epilepsy

Stopped early · Phase 2

Conditions studied: Epilepsy

In brief

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.

Key facts

Study ID

NCT01494584

Run by

GlaxoSmithKline

People needed

5

Starts

2012-07-25

Expected to finish

2013-04-29

Last updated by the study team

2020-11-30

Who can join

Age: 12 and older, up to 17. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• GSK Investigational Site — Los Angeles, California, United States
• GSK Investigational Site — Wellington, Florida, United States
• GSK Investigational Site — Memphis, Tennessee, United States
• GSK Investigational Site — Dallas, Texas, United States

Full record on ClinicalTrials.gov

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