Assessment of the Efficacy and Safety of 2 Doses of Retigabine Immediate Release (900 mg/Day and 600 mg/Day) Used as Adjunctive Therapy in Adult Asian Subjects With Drug-resistant Partial-onset Seizures

PHASE3TerminatedINTERVENTIONAL
Enrollment

76

Participants

Timeline

Start Date

August 29, 2012

Primary Completion Date

December 1, 2013

Study Completion Date

December 23, 2013

Conditions
Epilepsy
Interventions
DRUG

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.

DRUG

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.

OTHER

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.

Trial Locations (41)

110

GSK Investigational Site, Taipei

333

GSK Investigational Site, Tau-Yuan

386

GSK Investigational Site, Kaohsiumg

1003

GSK Investigational Site, Manila

6000

GSK Investigational Site, Cebu City

8000

GSK Investigational Site, Davao City

10016

GSK Investigational Site, New Taipei City

10330

GSK Investigational Site, Bangkok

10400

GSK Investigational Site, Bangkok

11031

GSK Investigational Site, Taipei

13700

GSK Investigational Site, Seberang Jaya

40002

GSK Investigational Site, Khon Kaen

40705

GSK Investigational Site, Taichung

50006

GSK Investigational Site, Changhua

50200

GSK Investigational Site, Chiang Mai

59100

GSK Investigational Site, Kuala Lumpur

70403

GSK Investigational Site, Tainan City

71004

GSK Investigational Site, Tainan City

83301

GSK Investigational Site, Kaohsiung City

119074

GSK Investigational Site, Singapore

Unknown

GSK Investigational Site, Hang Hau

GSK Investigational Site, Hong Kong

GSK Investigational Site, Kowloon

GSK Investigational Site, Shatin

602-715

GSK Investigational Site, Busan

612-865

GSK Investigational Site, Busan

700-712

GSK Investigational Site, Daegu

705-718

GSK Investigational Site, Daegu

301-721

GSK Investigational Site, Daejeon

442-723

GSK Investigational Site, Gyeonggi-do

463-707

GSK Investigational Site, Gyeonggi-do

405-760

GSK Investigational Site, Incheon

110-744

GSK Investigational Site, Seoul

120-752

GSK Investigational Site, Seoul

135-710

GSK Investigational Site, Seoul

135-720

GSK Investigational Site, Seoul

136-705

GSK Investigational Site, Seoul

137-701

GSK Investigational Site, Seoul

138-736

GSK Investigational Site, Seoul

143-729

GSK Investigational Site, Seoul

150-713

GSK Investigational Site, Seoul

Sponsors

Lead Sponsor

All Listed Sponsors
lead

GlaxoSmithKline

INDUSTRY

NCT01648101 - Assessment of the Efficacy and Safety of 2 Doses of Retigabine Immediate Release (900 mg/Day and 600 mg/Day) Used as Adjunctive Therapy in Adult Asian Subjects With Drug-resistant Partial-onset Seizures | Biotech Hunter | Biotech Hunter