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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: September 13, 2012
Last verified: September 2012
History of Changes

March 30, 2006
September 13, 2012
July 2006
July 2014   (final data collection date for primary outcome measure)
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 ]
  • Percentage change in the monthly seizure rate from the baseline phase to the open-label treatment phase.
  • Vital signs
  • Weight
  • Clinical Lab Evaluations (blood chemistry, hematology, and urinalysis)
  • 12-lead ECGs
  • Physical and neurological examinations
  • Evaluations of adverse events.
  • American Urological Association Symptom Index
  • Post-void residual bladder ultrasound
Complete list of historical versions of study NCT00310388 on ClinicalTrials.gov Archive Site
  • 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 ]
Proportion of responders (patients experiencing at least a 50% reduction in seizure frequency) from baseline to the open-label treatment phase.
Not Provided
Not Provided
 
Open-Label Extension Study of the Phase 3 VRX-RET-E22-302 Double-Blind Trial
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)

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.

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.
Interventional
Phase 3
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Epilepsy
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
Experimental: Retigabine (INN), Ezogabine (USAN)
Retigabine (Ezogabine): all subjects
Intervention: Drug: Retigabine (INN), Ezogabine (USAN)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
376
July 2014
July 2014   (final data collection date for primary outcome measure)

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.
Both
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
Australia,   Belgium,   France,   Germany,   Hungary,   Israel,   Poland,   Russian Federation,   South Africa,   Spain,   Ukraine,   United Kingdom
 
NCT00310388
VRX-RET-E22-304, EUDRACT No. 2006-000956-42, RTG115097
No
GlaxoSmithKline
GlaxoSmithKline
Not Provided
Study Director: GSK Clinical Trials GlaxoSmithKline
GlaxoSmithKline
September 2012

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