Dysport® Treatment of Urinary Incontinence in Adults Subjects With Neurogenic Detrusor Overactivity (NDO) Due to Spinal Cord Injury or Multiple Sclerosis - Study 1 (CONTENT1)
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| ClinicalTrials.gov Identifier: NCT02660138 |
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Recruitment Status :
Active, not recruiting
First Posted : January 21, 2016
Last Update Posted : November 30, 2018
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Sponsor:
Ipsen
Information provided by (Responsible Party):
Ipsen
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Brief Summary:
The purpose of this study is to provide confirmatory evidence of the safety and efficacy of two Dysport® (AbobotulinumtoxinA) doses (600 units [U] and 800 U), compared to placebo in reducing urinary incontinence (UI) in adult subjects treated for neurogenic detrusor overactivity (NDO) due to spinal cord injury (SCI) or multiple sclerosis (MS).
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Urinary Incontinence Overactive Bladder | Drug: AbobotulinumtoxinA Drug: AbobotulinumtoxinA Placebo | Phase 3 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 217 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Triple (Participant, Care Provider, Investigator) |
| Primary Purpose: | Treatment |
| Official Title: | A Phase III, Multicentre, Randomised, Double Blind, Parallel Group, Placebo Controlled Study To Assess The Efficacy And Safety Of One Or More Intradetrusor Treatments Of 600 Or 800 Units of Dysport® For The Treatment Of Urinary Incontinence In Subjects With Neurogenic Detrusor Overactivity Due To Spinal Cord Injury Or Multiple Sclerosis |
| Study Start Date : | March 2016 |
| Estimated Primary Completion Date : | November 2018 |
| Estimated Study Completion Date : | March 31, 2019 |
Resource links provided by the National Library of Medicine
Genetics Home Reference related topics:
Multiple sclerosis
MedlinePlus related topics:
Bedwetting
Botox
Multiple Sclerosis
Spinal Cord Injuries
Urinary Incontinence
| Arm | Intervention/treatment |
|---|---|
| Experimental: 600 U Dysport® Group |
Drug: AbobotulinumtoxinA
600 U intra detrusor injection in two treatment periods (Initial and Retreatment phase) delivered at 30 injection points
Other Names:
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| Placebo Comparator: 600 U Dysport® Placebo Group |
Drug: AbobotulinumtoxinA Placebo
AbobotulinumtoxinA Placebo 600 U intra detrusor injection in two treatment periods (Initial and Retreatment phase) delivered at 30 injection points |
| Experimental: 800 U Dysport® Group |
Drug: AbobotulinumtoxinA
800 U intra detrusor injection in two treatment periods (Initial and Retreatment phase) delivered at 30 injection points
Other Names:
|
| Placebo Comparator: 800 U Dysport® Placebo Group |
Drug: AbobotulinumtoxinA Placebo
AbobotulinumtoxinA Placebo 800 U intra detrusor injection in two treatment periods (Initial and Retreatment phase) delivered at 30 injection points |
Primary Outcome Measures :
- Change in weekly number of UI episodes [ Time Frame: Baseline, 6 weeks ]Measured on a 7-day bladder diary
Secondary Outcome Measures :
- Change in maximum cystometric capacity (MCC) [ Time Frame: Baseline, 6 weeks ]MCC is maximum amount of fluid the bladder can hold.
- Change in maximum detrusor pressure (MDP) during storage [ Time Frame: Baseline, 6 weeks ]MDP is maximum pressure that occurs in the bladder when the bladder is storing fluid.
- Change in volume at first involuntary detrusor contraction (Vol@1stIDC) [ Time Frame: Baseline, 6 weeks ]Volume at first involuntary detrusor contraction is amount of fluid in the bladder when the bladder first starts having abnormal contractions
- Proportion of subjects with no episodes of UI [ Time Frame: Baseline, 6 weeks ]Measured on a 7-day bladder diary
- Proportion of subjects with no involuntary detrusor contraction (IDCs) during storage [ Time Frame: Baseline, 6 weeks ]Measured by urodynamic filling cystometry
- Change in incontinence quality of life (I-QoL) total summary score [ Time Frame: Baseline, 6 weeks ]Patient-reported outcome questionnaire
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| Ages Eligible for Study: | 18 Years to 80 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Key Inclusion Criteria:
- Urinary Incontinence for at least 3 months prior to Screening as a result of Neurogenic Detrusor Overactivity due to Spinal Cord Injury or Multiple Sclerosis.
- Subjects with Spinal Cord Injury must have a stable neurological injury at T1 level or below which occurred at least 6 months prior to Screening.
- Subjects with Multiple Sclerosis must be clinically stable in the investigator's opinion, with no exacerbation (relapse) of MS for at least 3 months prior to Screening.
- Subjects must have had an inadequate response after at least 4 weeks of oral medications used in the treatment of NDO (e.g. anticholinergics, beta-3 agonists) and/or have intolerable side-effects.
- Routinely performing Clean Intermittent Catheterization (CIC) to ensure adequate bladder emptying.
- An average of at least two episodes per day of Urinary Incontinence recorded on the screening bladder diary.
Key Exclusion Criteria:
- Any current condition (other than NDO) that may impact on bladder function.
- Previous or current, tumour or malignancy affecting the spinal column or spinal cord, or any other unstable cause of SCI.
- Any condition that will prevent cystoscopic treatment administration or CIC usage, e.g. urethral strictures.
- Current indwelling bladder catheter, or removal of indwelling bladder catheter less than 4 weeks prior to Screening.
- BTX-A treatment within 9 months prior to Screening for any urological condition (e.g. detrusor or urethral sphincter treatments).
- Any neuromodulation/electrostimulation usage for urinary symptoms/incontinence within 4 weeks prior to Screening. Any implanted neuromodulation device must be switched off at least 4 weeks prior to Screening.
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02660138
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Sponsors and Collaborators
Ipsen
Investigators
| Study Director: | Ipsen Medical Director | Ipsen |
| Responsible Party: | Ipsen |
| ClinicalTrials.gov Identifier: | NCT02660138 History of Changes |
| Other Study ID Numbers: |
D-FR-52120-222 2015-003471-30 ( EudraCT Number ) |
| First Posted: | January 21, 2016 Key Record Dates |
| Last Update Posted: | November 30, 2018 |
| Last Verified: | November 2018 |
| Studies a U.S. FDA-regulated Drug Product: | Yes | |
| Studies a U.S. FDA-regulated Device Product: | No | |
Additional relevant MeSH terms:
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Multiple Sclerosis Spinal Cord Injuries Urinary Incontinence Enuresis Urinary Bladder, Overactive Demyelinating Autoimmune Diseases, CNS Autoimmune Diseases of the Nervous System Nervous System Diseases Demyelinating Diseases Autoimmune Diseases Immune System Diseases Spinal Cord Diseases Central Nervous System Diseases Trauma, Nervous System Wounds and Injuries |
Urination Disorders Urologic Diseases Lower Urinary Tract Symptoms Urological Manifestations Signs and Symptoms Behavioral Symptoms Elimination Disorders Mental Disorders Urinary Bladder Diseases abobotulinumtoxinA Botulinum Toxins, Type A onabotulinumtoxinA Hemagglutinins Acetylcholine Release Inhibitors Membrane Transport Modulators |