76
Participants
Start Date
August 29, 2012
Primary Completion Date
December 1, 2013
Study Completion Date
December 23, 2013
Retigabine 900mg/day
Study drug will be administered three times a day in a double blind manner. The starting dose of retigabine will be 300 mg/day. This dose will be increased by 150 mg/day per week to reach the target dose of 900mg/day over a 4 week Titration Phase). The subject will then continue to receive 900mg/day for the next 12 weeks (Maintenance Phase). Eligible subjects will then be offered an opportunity to enter an open label extension (OLE) study. After a 4 week transition phase, eligible subjects will start the OLE on retigabine 900mg/day.
Retigabine 600mg/day
Study drug will be administered three times a day in a double blind manner. The starting dose of retigabine will be 300mg/day. This dose will be increased by 150 mg/day per week to reach the target dose of 600mg/day over 2 weeks. The subject will then continue to receive 600mg/day for the next 14 weeks (2 weeks of the Titration Phase and 12 weeks of the Maintenance Phase). Eligible subjects will then be offered an opportunity to enter an open label extension (OLE) study. After a 4 week Transition Phase (3 weeks on retigabine 600mg/day, 1 week on retigabine 750mg/day) eligible subjects will start the OLE on retigabine 900mg/day.
Placebo
Study drug will be administered three times a day in a double blind manner. Subjects randomised to placebo will receive the same number, size and colour of tablets as the 600mg/day and 900mg/day treatment arms for the duration of the 4 week Titration Phase and the 12 week Maintenance Phase. Eligible subjects will then be offered an opportunity to enter an open label extension (OLE) study. The starting dose of retigabine will be 300 mg/day. This dose will be increased by 150 mg/day per week to reach dose of 750mg/day over the 4 weeks of the Transition Phase. On completion of the Transition Phase eligible subjects will start the OLE on retigabine 900mg/day.
GSK Investigational Site, Taipei
GSK Investigational Site, Tau-Yuan
GSK Investigational Site, Kaohsiumg
GSK Investigational Site, Manila
GSK Investigational Site, Cebu City
GSK Investigational Site, Davao City
GSK Investigational Site, New Taipei City
GSK Investigational Site, Bangkok
GSK Investigational Site, Bangkok
GSK Investigational Site, Taipei
GSK Investigational Site, Seberang Jaya
GSK Investigational Site, Khon Kaen
GSK Investigational Site, Taichung
GSK Investigational Site, Changhua
GSK Investigational Site, Chiang Mai
GSK Investigational Site, Kuala Lumpur
GSK Investigational Site, Tainan City
GSK Investigational Site, Tainan City
GSK Investigational Site, Kaohsiung City
GSK Investigational Site, Singapore
GSK Investigational Site, Hang Hau
GSK Investigational Site, Hong Kong
GSK Investigational Site, Kowloon
GSK Investigational Site, Shatin
GSK Investigational Site, Busan
GSK Investigational Site, Busan
GSK Investigational Site, Daegu
GSK Investigational Site, Daegu
GSK Investigational Site, Daejeon
GSK Investigational Site, Gyeonggi-do
GSK Investigational Site, Gyeonggi-do
GSK Investigational Site, Incheon
GSK Investigational Site, Seoul
GSK Investigational Site, Seoul
GSK Investigational Site, Seoul
GSK Investigational Site, Seoul
GSK Investigational Site, Seoul
GSK Investigational Site, Seoul
GSK Investigational Site, Seoul
GSK Investigational Site, Seoul
GSK Investigational Site, Seoul
Lead Sponsor
GlaxoSmithKline
INDUSTRY