Study in pediatric subjects with epilepsy

• Conditions: ncontrolled partial onset seizures or Lennox Gastaut Syndrome; MedDRA version: 14.1Level: PTClassification code 10061334Term: Partial seizuresSystem Organ Class: 10029205 - Nervous system disorders; MedDRA version: 14.1Level: PTClassification code 10048816Term: Lennox-Gastaut syndromeSystem Organ Class: 10029205 - Nervous system disorders; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: EUCTR2012-001132-60-Outside-EU/EEA
• Lead Sponsor: GlaxoSmithKline R&D Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-03-09
• Last Update Posted: 20 March 2012

Recruitment & Eligibility

• Status: A
• Sex: All
• Target Recruitment: 16

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.

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

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To characterize the pharmacokinetic profile of repeat doses of ezogabine/retigabine IR tablet in subjects aged 12 to less than 18 years old.;Secondary Objective: To assess the safety, tolerability, and efficacy of repeat doses of ezogabine/retigabine IR tablet in subjects aged 12 to less than 18 years old.<br>To determine the systemic exposure of the n-acetyl metabolite of ezogabine/retigabine (NAMR) after dosing ezogabine/retigabine IR tablets to steady-state.;Primary end point(s): Steady-state pharmacokinetics following oral administration of ezogabine/retigabine including clearance (Cl/F), volume of distribution (V/F), area under the curve over the dosing interval (AUC (0-tau)), maximum observed plasma concentration (Cmax)and trough plasma concentrations (Ctau);Timepoint(s) of evaluation of this end point: 5 to 8 timepoints at the end of weeks 1, 3, and 5.

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Tolerability: Incidence of adverse events, clinical laboratory parameters, ECG parameters, vital signs, monitoring of bladder function and CNS symptoms as appropriate<br>• Monitoring of seizure frequency<br>• Estimate of systemic exposure to the n-acetyl metabolite of ezogabine/retigabine (NAMR) (AUC(0-tau), and Ctau)<br>• Ezogabine/retigabine time to maximum concentration (tmax) and half-life at steadystate (t1/2) (if data allow);Timepoint(s) of evaluation of this end point: Safety parameters - Subjects will be followed until the end of titration, an expected average of 5 weeks.<br>Seizure frequency - Subjects will be followed until the end of titration, an expected average of 5 weeks.<br>Estimate of systemic exposure to the n-acetyl metabolite - 5 to 8 timepoints at the end of weeks 1, 3, and 5.<br>Phamacokinetic parameters - 5 to 8 timepoints at the end of weeks 1, 3, and 5.