Safety and Efficacy Study of AGN-214868 in Patients With Idiopathic Overactive Bladder and Urinary Incontinence

Study Overview
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Brief Summary
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This study will evaluate the safety and efficacy of AGN-214868 in patients with idiopathic overactive bladder (IOAB) and urinary incontinence.

Conditions
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Urinary Bladder, Overactive

Intervention / Treatment
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* Drug: AGN-214868
* Drug: AGN-214868 placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: If female, must be of nonreproductive potential If male, must agree to use acceptable contraception Symptoms of overactive bladder with urinary urgency incontinence Inadequate response or limiting side effects with anticholinergics for the treatment of OAB Exclusion Criteria: Overactive bladder caused by neurological condition (eg, spinal cord injury, multiple sclerosis) History of bladder surgery Treatment with botulinum toxin therapy of any serotype for any non-urological condition within the prior 12 weeks Previous treatment with botulinum toxin therapy of any serotype for any urological condition

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: AGN-214868 total dose 500 ng<br>AGN-214868 injected into the bladder for total dose of 500 ng on Day 1. | Drug: AGN-214868<br>* AGN-214868 injected into the bladder.<br>|
| Experimental: AGN-214868 total dose 1000 ng<br>AGN-214868 injected into the bladder for total dose of 1000 ng on Day 1. | Drug: AGN-214868<br>* AGN-214868 injected into the bladder.<br>|
| Experimental: AGN-214868 total dose 2000 ng<br>AGN-214868 injected into the bladder for total dose of 2000 ng on Day 1. | Drug: AGN-214868<br>* AGN-214868 injected into the bladder.<br>|
| Experimental: AGN-214868 total dose 6000 ng<br>AGN-214868 injected into the bladder for total dose of 6000 ng on Day 1. | Drug: AGN-214868<br>* AGN-214868 injected into the bladder.<br>|
| Experimental: AGN-214868 total dose 18000 ng<br>AGN-214868 injected into the bladder for total dose of 18000 ng on Day 1. | Drug: AGN-214868<br>* AGN-214868 injected into the bladder.<br>|
| Experimental: AGN-214868 total dose 60000 ng<br>AGN-214868 injected into the bladder for total dose of 60000 ng on Day 1. | Drug: AGN-214868<br>* AGN-214868 injected into the bladder.<br>|
| Placebo Comparator: Placebo to AGN-214868<br>Placebo to AGN-214868 injected into the bladder on Day 1. | Drug: AGN-214868 placebo<br>* AGN-214868 placebo injected into the bladder.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in the Daily Average Number of Micturition (Urination) Episodes | The average number of urinary episodes (urination into the toilet) was recorded by a patient bladder diary during 3 consecutive days in the week prior to Baseline and Week 12. A negative change from Baseline indicated improvement (fewer urinary episodes). | Baseline, Week 12 |