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

Targacept

Status and phase: Completed; Phase 2

Conditions: Overactive Bladder

Treatments: Drug: dexmecamylamine; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01868516

TC-5214-23-CRD-003

Details and patient eligibility

About

Overactive bladder (OAB) is a syndrome characterized by symptoms of a sudden need to urinate with or without incontinence (leaking). The purpose of this study is to test whether dexmecamylamine is safe and effective compared to placebo for the treatment of symptoms of OAB.

Full description

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.

Enrollment: 1,635 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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1,635 participants in 4 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

One tablet of placebo to be administered orally twice a day.

Treatment:

Drug: Placebo

0.5 mg dexmecamylamine (TC-5214)

Experimental group

Description:

One tablet of 0.5 mg dexmecamylamine to be administered orally twice a day.

Treatment:

Drug: dexmecamylamine

1 mg dexmecamylamine (TC-5214)

Experimental group

Description:

One tablet of 1 mg dexmecamylamine to be administered orally twice a day.

Treatment:

Drug: dexmecamylamine

2 mg dexmecamylamine (TC-5214)

Experimental group

Description:

One tablet of 2 mg dexmecamylamine to be administered orally twice a day.

Treatment:

Drug: dexmecamylamine