Status:
TERMINATED
Open-Label Extension Study of the Phase 3 VRX-RET-E22-302 Double-Blind Trial. 115097
Lead Sponsor:
GlaxoSmithKline
Conditions:
Epilepsy
Eligibility:
All Genders
18-75 years
Phase:
PHASE3
Brief Summary
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 excl...
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 excl...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 5 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 24 2018
Estimated Enrollment :
376 Patients enrolled
Trial Details
Trial ID
NCT00310388
Start Date
July 5 2006
End Date
May 24 2018
Last Update
November 15 2018
Active Locations (67)
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1
Institute of Clniical Neurosciences
Camperdown, New South Wales, Australia, 2050
2
North Coast Neurology Centre
Maroochydore, Queensland, Australia, 4558
3
Flinders Medical Centre
Bedford Park, South Australia, Australia, 5041
4
Royal Melbourne Hospital
Parkville, Victoria, Australia, 3050