Dataset from A Phase III Study to Evaluate the Efficacy and Safety of GSK1358820 (Botulinum Toxin Type A) in Patients With Overactive Bladder

GSK1358820 is a botulinum neurotoxin A complex that has been approved for the treatment of
overactive bladder (OAB) in several countries, however, it has not been approved for OAB
treatment in Japan. This study has been planned to evaluate the efficacy and safety of
GSK1358820 in Japanese OAB patients with urinary incontinence whose symptoms have not been
adequately managed with other medications for OAB.

The primary objective of this study is to evaluate the superiority of a single dose treatment
of GSK1358820 100 units (U) compared with placebo.

The study comprises a screening phase up to 28 days, followed by a double-blind treatment
phase of 12 to 48 weeks wherein subjects will receive a single treatment of either GSK1358820
100 U injection or Placebo injection, in a ratio of 1:1, with further stratification within
the treatment arms according to the number of urinary urge incontinence episodes during
screening. Subjects meeting the criteria for re-treatment will receive a second and third
treatment. Each re-treatment will be with open-label GSK1358820 100 U injection, and will be
spaced at least 12 weeks from the previous treatment.

The total duration of participation for any subject will not exceed 52 weeks, including
screening and the 48-week treatment period.