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
  Purpose

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.


Condition Intervention Phase
Epilepsy
Drug: ezogabine/retigabine
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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


Enrollment: 5
Study Start Date: July 2012
Study Completion Date: April 2013
Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ezogabine/retigabine
ezogabine dose escalation
Drug: ezogabine/retigabine
ezogabine dose escalation

  Eligibility

Ages Eligible for Study:   12 Years to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01494584

Locations
United States, California
GSK Investigational Site
Los Angeles, California, United States, 90027
United States, Florida
GSK Investigational Site
Gulf Breeze, Florida, United States, 32561
GSK Investigational Site
Port Charlotte, Florida, United States, 33952
GSK Investigational Site
Wellington, Florida, United States, 33414
United States, Minnesota
GSK Investigational Site
St. Paul, Minnesota, United States, 55102-2534
United States, North Carolina
GSK Investigational Site
Durham, North Carolina, United States, 27710
United States, Tennessee
GSK Investigational Site
Memphis, Tennessee, United States, 38105
United States, Texas
GSK Investigational Site
Austin, Texas, United States, 78723
GSK Investigational Site
Dallas, Texas, United States, 75230-2507
Sponsors and Collaborators
GlaxoSmithKline
Valeant Pharmaceuticals International, Inc.
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01494584     History of Changes
Other Study ID Numbers: 113284
Study First Received: December 1, 2011
Last Updated: May 29, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Epilepsy
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
D 23129
Anticonvulsants
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 20, 2014