Safety and Efficacy of SAF312 in Patients With Neurogenic Detrusor Overactivity Due to Spinal Cord Lesions

Study Overview
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Brief Summary
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This study will assess the safety, tolerability and efficacy of SAF312 in patients with overactive bladder disease due to spinal cord lesions. The overactive bladder of patients who qualify for this study is insufficiently managed by antimuscarinic therapy, or patients poorly tolerate the treatment with antimuscarinic drugs. The efficacy of SAF312 will be primarily determined via urodynamic measurements.

Official Title
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A Multi-center, Double-blind, Randomized, Placebo-controlled, Cross-over Study to Evaluate the Efficacy, Safety and Tolerability of SAF312 in Subjects With Neurogenic Detrusor Overactivity Due to Spinal Cord Lesions Who Are Inadequately Managed by Antimuscarinic Therapy

Conditions
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Neurogenic Urinary Bladder, Neurogenic Bladder Disorder, Neurogenic Dysfunction of the Urinary Bladder, Neurogenic Bladder, Uninhibited, Neurogenic Bladder, Spastic

Intervention / Treatment
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* Drug: SAF312
* Drug: Placebo to SAF312


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with neurogenic detrusor overactivity due to spinal cord lesions Patients are inadequately managed by antimuscarinic medication and present with a cystometric bladder capacity of max. 400 mL Exclusion Criteria: Chronic inflammation such as interstitial cystitis, bladder stones, hematuria of unknown origin, previous pelvic radiation therapy or previous or current malignant disease of the pelvic organs Pelvic or genitourinary tract anomalies including surgery or bladder disease other than detrusor overactivity impacting on bladder function

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 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: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo to SAF312<br> | Drug: Placebo to SAF312<br>* One week of treatment in a BID (two times a day) regimen (hard gelatin capsules for oral use)<br>|
| Experimental: SAF312<br> | Drug: SAF312<br>* One week of treatment in a BID (two times a day) regimen (hard gelatin capsules for oral use)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum cystometric capacity (MCC) | Examined during filling cystometry as measured by changes from baseline following treatment for one week. | 1 week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants with Adverse Events as a Measure of Safety | Safety (physical exam, vital signs, haematology, coagulation parameters, clinical chemistry and urinalysis, ECG, pregnancy test, hand immersion test and PK [concentrations of SAF312 in blood]). | 1 week | 
| Bladder threshold vol, threshold pressure, instilled vol at first leak, detrusor pressure at first leak, vol/detrusor pressure at first sensation and at first desire to void, maximum detrusor pressure during filling/storage, bladder wall compliance | All parameters examined during filling cystometry as measured by changes from baseline following treatment for one week | 1 week | 
| Micturition or catheterization frequency | Changes from baseline, as measured by daily diaries. | 1 week | 
| Incontinence episodes | Changes from baseline as measured by daily diaries. | 1 week | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Neurogenic detrusor overactivity, spinal cord lesions, spinal cord injury