Open-label, multiple dose study to evaluate thepharmacokinetics, safety and tolerability of ezogabine/retigabineas adjunctive treatment in subjects aged from 12 years to lessthan 18 years with partial onset seizures or Lennox-Gastautsyndrome

GlaxoSmithKline R&D Limited0 个研究点目标入组 16 人开始时间: 2012年3月9日最近更新: 2012年3月20日

适应症

试验速览

暂无简介。

•- 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.
•Are the trial subjects under 18? yes
•Number of subjects for this age range: 16
•F.1.2 Adults (18-64 years) no
•F.1.2.1 Number of subjects for this age range
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•- 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.

发起方

GlaxoSmithKline R&D Limited