Study Evaluating the Safety, Tolerability, and Efficacy of Dexmecamylamine (TC-5214) for Treatment of Overactive Bladder

The study included a three- or five-week screening period, followed by a 12-week treatment period during which patients received either one of three doses of dexmecamylamine or placebo twice daily, randomized in a ratio of 2:1:1:1 (placebo, low dose, mid dose, high dose), with a two-week follow-up period. A total of 768 subjects with overactive bladder were randomized into the double-blind treatment period of the study.

Inclusion criteria

• Verified medical history of overactive bladder for at least 6 months
• Capable of walking unassisted to use the bathroom
• Able to measure voided urine volume and complete the diary without assistance
• If the subject is currently being treated with an OAB medication, the subject is willing to discontinue OAB medications while participating in this study

Exclusion criteria

• Diagnosis of a neurological disease affecting bladder function
• Stress incontinence, insensate incontinence, overflow incontinence or incontinence due to urinary fistula
• History of incomplete bladder emptying, bladder outflow obstruction or post-void residual bladder volume > 150 mL
• Males with benign prostatic hyperplasia or with a prostate-specific antigen (PSA) of 4 ng/mL or more
• Other urinary tract pathology such as malignancy, ureteric reflux, bladder stone, uninvestigated hematuria, urethral stricture, or cystitis
• Prior treatment with intravesical or intraprostatic botulinum toxin in the last 2 years
• Myasthenia gravis
• Angle closure glaucoma
• Current implantation of interstim electrodes or vaginal surgical mesh
• Presence of a clinically significant medical condition at any time during the study
• Presence of clinically significant abnormalities in laboratory findings, physical exam findings or vital signs
• Participated in an investigational drug trial within 3 months of screening