Open-Label Extension Study of the Phase 3 VRX-RET-E22-302 Double-Blind Trial

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00310388
First received: March 30, 2006
Last updated: November 7, 2013
Last verified: November 2013
  Purpose

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-E22-302 double-blind study. The efficacy of long-term treatment with retigabine and patient quality of life will also be assessed.


Condition Intervention Phase
Epilepsy
Drug: Retigabine (INN), Ezogabine (USAN)
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
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-E22-302)

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: 376
Study Start Date: July 2006
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Retigabine (INN), Ezogabine (USAN)
Retigabine (Ezogabine): all subjects
Drug: Retigabine (INN), Ezogabine (USAN)
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 patients receives between 600 and 1200 mg of retigabine per day. The duration will be until the completion of the trial, or until the patient withdraws from the trial.
Other Names:
  • GW582892X
  • D-23129
  • GKE-841

Detailed Description:

This Phase 3 trial is an open-label extension study of the placebo-controlled, double-blind VRX-RET-E22-302 trial. Patients who have completed the VRX-RET-E22-302 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 55-60 sites in Europe, Israel, Australia, and South Africa. 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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patient has successfully completed the Maintenance and Transition phases of Study VRX-RET-E22-302 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-E22-302 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 ClinicalTrials.gov identifier: NCT00310388

  Show 67 Study Locations
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00310388     History of Changes
Other Study ID Numbers: VRX-RET-E22-304, EUDRACT No. 2006-000956-42, RTG115097
Study First Received: March 30, 2006
Last Updated: November 7, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:
Partial Seizures
Epilepsy
RTG115097
Complex Partial Seizures
Anticonvulsant
Potassium Channels
Epilepsies, Partial

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