Dataset from A Phase III Study to Evaluate the Efficacy and Safety of GSK1358820 (Botulinum Toxin Type A) in Patients With Urinary Incontinence Due to Neurogenic Detrusor Overactivity

This study will evaluate the efficacy and safety of GSK1358820 in Japanese patients with
neurogenic detrusor overactivity (NDO) with urinary incontinence, whose symptoms have not
been adequately managed with medications for urinary incontinence due to NDO.

This study consists of a screening phase up to 28 days followed by a double-blind Treatment
phase 1 of 12 to 48 weeks wherein subjects will receive a single treatment of either
GSK1358820 200 Units (U) injection or placebo injection. After the first treatment, subjects
who meet the re-treatment criteria between 12 to 36 weeks can enter an open-label Treatment
phase 2 to receive a second treatment with GSK1358820 200 U. Subjects will be permitted to
receive re-treatment up to 2 times, and there should be a gap of minimum of 12 weeks since
the previous treatment. The duration of overall treatment phases is 48 weeks. The total
duration of participation for any subject will not exceed 52 weeks, including screening.