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Open-label Extension Study of the Phase 3 VRX-RET-E22-301 Double-Blind Trial

This study has been completed.
Information provided by (Responsible Party):
GlaxoSmithKline Identifier:
First received: March 30, 2006
Last updated: April 7, 2016
Last verified: April 2016
The purpose of this study is to evaluate the safety and tolerability of long-term therapy with retigabine administered as adjunctive therapy in adult epilepsy patients with partial-onset seizures, who completed the VRX-RET-E22-301 double-blind study. The efficacy of long-term treatment with retigabine and patient quality of life will also be assessed.

Condition Intervention Phase
Drug: Ezogabine: USAN Retigabine (International Nonproprietary Name)
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Multicenter, Open-label, Long-term, Safety, Tolerability and Efficacy Study of Retigabine in Adult Epilepsy Patients With Partial-onset Seizures (Extension of Study VRX-RET-E22-301)

Resource links provided by NLM:

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Percentage change in the monthly seizure rate from the baseline phase to the open-label treatment phase. [ Time Frame: Frequency rates to be determined at end of the open-label treatment phase ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Reports of adverse events [ Time Frame: At selected study visits ] [ Designated as safety issue: Yes ]
  • Results of vital signs [ Time Frame: At selected study visits ] [ Designated as safety issue: Yes ]
  • Weight [ Time Frame: At selected study visits ] [ Designated as safety issue: Yes ]
  • Clinical laboratory evaluations [ Time Frame: At selected study visits ] [ Designated as safety issue: Yes ]
  • 12-lead ECG [ Time Frame: At selected study visits ] [ Designated as safety issue: Yes ]
  • Post-void residual bladder ultrasounds [ Time Frame: At selected study visits ] [ Designated as safety issue: Yes ]

Enrollment: 181
Study Start Date: May 2006
Study Completion Date: November 2015
Primary Completion Date: November 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Ezogabine: USAN Retigabine (International Nonproprietary Name)
Film-coated tablets - 50mg, 100mg or 300mg
Drug: Ezogabine: USAN Retigabine (International Nonproprietary Name)
Film-coated tablets containing 50 mg, 100 mg, or 300 mg of retigabine per tablet. Dosage and frequency will be specific to each patient so long as the patient receives between 600 and 1200 mg of retigabine per day. The duration will be until the trial concludes or the patient leaves the trial.
Other Names:
  • GKE-841
  • D-23129
  • GW582892X

Detailed Description:
This Phase 3 trial is an open-label extension study of the placebo-controlled, double-blind VRX-RET-E22-301 trial. Patients who have completed the VRX-RET-E22-301 trial and who meet inclusion and exclusion criteria will be treated with 600-1200 mg/day of retigabine as an adjunct therapy to their current antiepileptic drugs (AEDs) or vagal nerve stimulation. Treatment will be continued until retigabine is commercially available, or until the program is discontinued. Patients will be recruited from 45-50 sites in the United States, Canada, Mexico, Brazil, and Argentina. The safety and tolerability of long-term therapy with retigabine administered as adjunctive therapy in adult epilepsy patients with partial-onset seizures will be evaluated. In addition, the efficacy of long-term treatment with retigabine and patient quality of life will be assessed.

Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Patient has successfully completed the Maintenance and Transition phases of Study VRX-RET-E22-301 for the treatment of partial-onset seizures
  • Patient is expected to benefit from participation in the study in the opinion of the Investigator.

Exclusion Criteria:

  • Patient meets any of the withdrawal criteria in the previous VRX-RET-E22-301 study or is experiencing an ongoing serious adverse event.
  • Patient is receiving any investigational drug or using any experimental device in addition to Retigabine for treatment of epilepsy or any other medical condition.
  • Patient has any other condition that would prevent compliance with the study procedures or proper reporting of adverse events.
  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 identifier: NCT00310375

  Show 51 Study Locations
Sponsors and Collaborators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

Responsible Party: GlaxoSmithKline Identifier: NCT00310375     History of Changes
Other Study ID Numbers: VRX-RET-E22-303  RTG115098 
Study First Received: March 30, 2006
Last Updated: April 7, 2016
Health Authority: United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:
Partial Seizures
Potassium Channels
Complex Partial Seizures
Epilepsies, Partial

Additional relevant MeSH terms:
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action processed this record on October 27, 2016