Safety and Efficacy of AV608 in Subjects With Idiopathic Detrusor Overactivity

Study Overview
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Brief Summary
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The purpose of this study is to assess the effects of AV608, a neurokinin 1 (NK-1) antagonist, in subjects with Idiopathic Detrusor Overactivity.

Detailed Description
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This is a Phase 2, randomized, double-blind, placebo-controlled trial to evaluate the safety and efficacy of AV608 in subjects with idiopathic detrusor overactivity. Female subjects between 18 and 65 years of age with a diagnosis of Overactive Bladder Syndrome and urodynamic observation of involuntary detrusor contractions during the filling phase will be eligible for the trial. Eligible subjects will complete a baseline urodynamic assessment. All subjects who participate in the study will receive 3 weeks of treatment with AV608 or placebo. At the end of the treatment period, subjects will complete a second urodynamic assessment.

Official Title
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A Phase 2, Randomized, Double-Blind, Placebo-Controlled Trial to Investigate the Safety and Efficacy of AV608 in Subjects With Idiopathic Detrusor Overactivity

Conditions
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Overactive Bladder Syndrome

Intervention / Treatment
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* Drug: AV608


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Female, 18 to 65 years of age, inclusive A current primary diagnosis of OAB Idiopathic detrusor overactivity, demonstrated by a urodynamic observation Evidence of frequency in combination with urinary urgency Written informed consent form Willingness to avoid pregnancy and practice adequate birth control Negative serum pregnancy test Agrees to refrain from blood donation during the course of the study Exclusion Criteria: Subjects who are pregnant or lactating Clinically significant abnormality or clinically significant unstable medical condition QTc interval of 470 msec or greater at Visit 1 Predominant stress urinary incontinence versus urge urinary incontinence based on subject history Neurogenic bladder (e.g. associated with spinal cord injury, multiple sclerosis, etc.) Anatomic or structural abnormalities possibly causing urinary incontinence or urgency, including but not limited to urogenital prolapse stage 2 or more according to the Pelvic Organ Prolapse Quantification (POP-Q) system Urological or gynecological surgery within 3 months of the baseline urodynamic assessment Current UTI or frequent UTIs (i.e., greater than or equal to 4 UTIs per year), interstitial cystitis, hematuria of unknown cause, or use of indwelling catheter Electro-stimulation therapy, bladder training, or physiotherapy for bladder control within 2 weeks of Visit 1 History (within 1 year of Screening) of alcohol or substance dependence (except nicotine dependence) according to DSM-IV-TR criteria History of any kind of cancer within the last 2 years Existing non-malignant tumors that could compromise the function and/or anatomy of the lower urinary tract

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Female

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

| Intervention/Treatment |
| --- |
|Drug: AV608|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison between treatment groups of the change from baseline in maximum cystometric bladder capacity |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Delay of the first involuntary detrusor contraction associated with symptomatic urgency |  |  | 
| Urgency, frequency and urge incontinence events as recorded in the Subject Micturition Diary |  |  | 
| Urgency Perception Scale |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Idiopathic Detrusor Overactivity, NK-1 Receptor Antagonist, Neurokinin, Urge Incontinence