Study in Pediatric Subjects With Epilepsy

This study has been terminated.
(Terminated after placing the study on hold at the request of the FDA)
Sponsor:
Collaborator:
Valeant Pharmaceuticals International, Inc.
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01494584
First received: December 1, 2011
Last updated: May 29, 2014
Last verified: May 2014

December 1, 2011
May 29, 2014
July 2012
April 2013   (final data collection date for primary outcome measure)
Pharmacokinetic profile of steady-state pharmacokinetics [ Time Frame: 5 to 8 timepoints at the end of weeks 1, 3, and 5. ] [ Designated as safety issue: No ]
Clearance, volume of distribution, area under the curve over the dosing interval, maximum observed plasma concentration and trough plasma concentrations
Same as current
Complete list of historical versions of study NCT01494584 on ClinicalTrials.gov Archive Site
  • Safety parameters [ Time Frame: Subjects will be followed until the end of titration, an expected average of 5 weeks. ] [ Designated as safety issue: Yes ]
    Incidence of adverse events, clinical laboratory parameters, ECG parameters, vital signs, monitoring of bladder function and CNS syndrome
  • Seizure frequency [ Time Frame: Subjects will be followed until the end of titration, an expected average of 5 weeks. ] [ Designated as safety issue: No ]
  • Estimate of systemic exposure to the n-acetyl metabolite [ Time Frame: 5 to 8 timepoints at the end of weeks 1, 3, and 5. ] [ Designated as safety issue: No ]
  • Pharmacokinetic parameters [ Time Frame: 5 to 8 timepoints at the end of weeks 1, 3, and 5. ] [ Designated as safety issue: No ]
    Time to maximum concentration and half life at steady-state
  • Safety parameters [ Time Frame: Subjects will be followed until the end of titration, an expected average of 5 weeks. ] [ Designated as safety issue: Yes ]
    Incidence of adverse events, clinical laboratory parameters, ECG parameters, vital signs, monitoring of bladder function and CNS syndrome
  • Seizure frequency [ Time Frame: Subjects will be followed until the end of titration, an expected average of 5 weeks. ] [ Designated as safety issue: No ]
  • Estimate of systemic exposure to the n-acetyl metabolite [ Time Frame: 5 to 8 timepoints at the end of weeks 1, 3, and 5. ] [ Designated as safety issue: No ]
  • Phamacokinetic parameters [ Time Frame: 5 to 8 timepoints at the end of weeks 1, 3, and 5. ] [ Designated as safety issue: No ]
    Time to maximum concentration and half life at steady-state
Not Provided
Not Provided
 
Study in Pediatric Subjects With Epilepsy
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.

Not Provided
Interventional
Phase 2
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Epilepsy
Drug: ezogabine/retigabine
ezogabine dose escalation
Experimental: ezogabine/retigabine
ezogabine dose escalation
Intervention: Drug: ezogabine/retigabine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
5
April 2013
April 2013   (final data collection date for primary outcome measure)

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.
Both
12 Years to 17 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01494584
113284
No
GlaxoSmithKline
GlaxoSmithKline
Valeant Pharmaceuticals International, Inc.
Study Director: GSK Clinical Trials GlaxoSmithKline
GlaxoSmithKline
May 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP