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This study will evaluate the safety and efficacy of OnabotulinumtoxinA (BOTOX®) for the treatment of urinary incontinence due to NDO in non-catheterizing patients with MS.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| OnabotulinumtoxinA | Experimental | OnabotulinumtoxinA 100 U is administered into the detrusor at Day 1. After a minimum of 12 weeks, patients could request/qualify for a second onabotulinumtoxinA 100 U injection. |
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| Placebo (Normal Saline) | Other | Placebo (normal saline) is administered into the detrusor at Day 1. After a minimum of 12 weeks, patients could request/qualify for an onabotulinumtoxinA injection. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| OnabotulinumtoxinA | Biological | OnabotulinumtoxinA 100 U is administered into the detrusor at Day 1 in the onabotulinumtoxinA 100 U arm. After a minimum of 12 weeks, patients in both the onabotulinumtoxinA 100 U arm and the placebo arm could request/qualify for an onabotulinumtoxinA injection. |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Daily Average Frequency of Urinary Incontinence Episodes | Incontinence is defined as involuntary loss of urine as recorded in a patient bladder diary. The number of episodes of urinary incontinence is recorded over a 3-day period the week of the study visit. A negative number change from baseline indicates a reduction in incontinence episodes (improvement) and a positive number change indicates an increase in incontinence episodes (worsening). | Baseline, Week 6 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Maximum Cystometric Capacity (MCC) | MCC represents the maximum volume of urine the bladder holds. A positive number change from baseline represents an improvement (increase) in the maximum volume of urine the bladder holds and a negative number change from baseline represents a worsening (decrease) in the maximum volume of urine the bladder holds. | Baseline, Week 6 |
| Measure | Description | Time Frame |
|---|---|---|
| Duration of Treatment Effect Through Week 52 | The duration of treatment effect is the time to patient request for retreatment. | Up to 52 Weeks |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Allergan | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mountlake Terrace | Washington | United States | ||||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30030330 | Background | Tullman M, Chartier-Kastler E, Kohan A, Keppenne V, Brucker BM, Egerdie B, Mandle M, Nicandro JP, Jenkins B, Denys P. Low-dose onabotulinumtoxinA improves urinary symptoms in noncatheterizing patients with MS. Neurology. 2018 Aug 14;91(7):e657-e665. doi: 10.1212/WNL.0000000000005991. Epub 2018 Jul 20. |
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| ID | Title | Description |
|---|---|---|
| FG000 | OnabotulinumtoxinA | OnabotulinumtoxinA 100 U is administered into the detrusor at Day 1. After a minimum of 12 weeks, patients could request/qualify for a second onabotulinumtoxinA injection. |
| FG001 | Placebo (Normal Saline) |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Placebo (Normal Saline) | Drug | Placebo (normal saline) is administered into the detrusor at Day 1. |
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| Change From Baseline in Maximum Detrusor Pressure During the First Involuntary Detrusor Contraction (IDC) | Maximum detrusor pressure represents the maximum pressure (peak amplitude) in the bladder during the first involuntary contraction of the bladder muscle. A negative number change from baseline indicates an improvement in pressure and a positive number change from baseline indicates a worsening in pressure. | Baseline, Week 6 |
| Change From Baseline in Incontinence Quality of Life Instrument (I-QOL) Total Summary Score | The I-QOL is a validated, disease-specific quality of life (QOL) questionnaire containing 22 questions designed to measure impact of urinary incontinence on patients' lives. Each question is answered on a 5-point scale (1 = worst QOL, and 5 = best QOL). The scores are totaled over the 22 questions and normalized to a score of 0-100 (0=worst QOL and 100=best QOL). A positive change from baseline represents an improvement and a negative change from baseline represents a worsening. | Baseline, Week 6 |
| Liège |
| Belgium |
| Victoria | British Columbia | Canada |
| Kitchener | Ontario | Canada |
| Olomouc | Czechia |
| Garches | France |
| Marseille | France |
| Warsaw | Poland |
| Porto | Portugal |
| Saint Petersburg | Russia |
Placebo (normal saline) is administered into the detrusor at Day 1. After a minimum of 12 weeks, patients could request/qualify for an onabotulinumtoxinA injection.
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | OnabotulinumtoxinA | OnabotulinumtoxinA 100 U is administered into the detrusor at Day 1. After a minimum of 12 weeks, patients could request/qualify for a second onabotulinumtoxinA injection. |
| BG001 | Placebo (Normal Saline) | Placebo (normal saline) is administered into the detrusor at Day 1. After a minimum of 12 weeks, patients could request/qualify for an onabotulinumtoxinA injection. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
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| Age, Customized | Count of Participants | Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change From Baseline in Daily Average Frequency of Urinary Incontinence Episodes | Incontinence is defined as involuntary loss of urine as recorded in a patient bladder diary. The number of episodes of urinary incontinence is recorded over a 3-day period the week of the study visit. A negative number change from baseline indicates a reduction in incontinence episodes (improvement) and a positive number change indicates an increase in incontinence episodes (worsening). | Intent-to-Treat Population: all randomized patients | Posted | Mean | Standard Deviation | Episodes | Baseline, Week 6 |
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| Secondary | Change From Baseline in Maximum Cystometric Capacity (MCC) | MCC represents the maximum volume of urine the bladder holds. A positive number change from baseline represents an improvement (increase) in the maximum volume of urine the bladder holds and a negative number change from baseline represents a worsening (decrease) in the maximum volume of urine the bladder holds. | Intent-to-Treat Population: all randomized patients with data at the time points | Posted | Mean | Standard Deviation | Milliliters (mL) | Baseline, Week 6 |
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| Secondary | Change From Baseline in Maximum Detrusor Pressure During the First Involuntary Detrusor Contraction (IDC) | Maximum detrusor pressure represents the maximum pressure (peak amplitude) in the bladder during the first involuntary contraction of the bladder muscle. A negative number change from baseline indicates an improvement in pressure and a positive number change from baseline indicates a worsening in pressure. | Intent-to-Treat Population: all randomized patients with data at the time points | Posted | Mean | Standard Deviation | Centimeters of Water (cm H2O) | Baseline, Week 6 |
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| Secondary | Change From Baseline in Incontinence Quality of Life Instrument (I-QOL) Total Summary Score | The I-QOL is a validated, disease-specific quality of life (QOL) questionnaire containing 22 questions designed to measure impact of urinary incontinence on patients' lives. Each question is answered on a 5-point scale (1 = worst QOL, and 5 = best QOL). The scores are totaled over the 22 questions and normalized to a score of 0-100 (0=worst QOL and 100=best QOL). A positive change from baseline represents an improvement and a negative change from baseline represents a worsening. | Intent-to-Treat Population: all randomized patients with data at the time points | Posted | Mean | Standard Deviation | Scores on a Scale | Baseline, Week 6 |
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| Other Pre-specified | Duration of Treatment Effect Through Week 52 | The duration of treatment effect is the time to patient request for retreatment. | Intent-to-Treat Population: all randomized patients | Posted | Median | 95% Confidence Interval | Weeks | Up to 52 Weeks |
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Adverse events and serious adverse events are analyzed by treatment cycle (cycle 1 and cycle 2).
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | OnabotulinumtoxinA Treatment Cycle 1 | OnabotulinumtoxinA 100 U is administered into the detrusor at Day 1. Median duration of exposure is 50.7 weeks. | 7 | 66 | 50 | 66 | ||
| EG001 | Placebo (Normal Saline) | Placebo (normal saline) is administered into the detrusor at Day 1. Median duration of exposure is 15.2 weeks. | 3 | 78 | 44 | 78 | ||
| EG002 | OnabotulinumtoxinA/OnabotulinumtoxinA Treatment Cycle 2 | OnabotulinumtoxinA 100 U is administered into the detrusor at Day 1. After a minimum of 12 weeks, a second onabotulinumtoxinA injection is given. Median duration of exposure is 12.5 weeks. | 0 | 30 | 21 | 30 | ||
| EG003 | Placebo (Normal Saline)/OnabotulinumtoxinA | Placebo (normal saline) is administered into the detrusor at Day 1. After a minimum of 12 weeks, an onabotulinumtoxinA injection is given. Median duration of exposure is 12.2 weeks. | 2 | 67 | 38 | 67 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acute Coronary Syndrome | Cardiac disorders | MedDRA version 17.1 | Systematic Assessment |
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| Urinary Tract Infection | Infections and infestations | MedDRA version 17.1 | Systematic Assessment |
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| Infectious Colitis | Infections and infestations | MedDRA version 17.1 | Systematic Assessment |
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| Spinal Compression Fracture | Injury, poisoning and procedural complications | MedDRA version 17.1 | Systematic Assessment |
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| Fall | Injury, poisoning and procedural complications | MedDRA version 17.1 | Non-systematic Assessment |
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| Muscular Weakness | Musculoskeletal and connective tissue disorders | MedDRA version 17.1 | Non-systematic Assessment | Onset date was 135 days after administration of onabotulinumtoxinA |
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| Multiple Sclerosis Relapse | Nervous system disorders | MedDRA version 17.1 | Non-systematic Assessment |
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| Pyrexia | General disorders | MedDRA version 17.1 | Non-systematic Assessment |
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| Dysuria | Renal and urinary disorders | MedDRA version 17.1 | Non-systematic Assessment |
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| Multiple sclerosis | Nervous system disorders | MedDRA version 17.1 | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Urinary tract infection | Infections and infestations | MedDRA version 17.1 | Systematic Assessment |
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| Urinary Retention | Renal and urinary disorders | MedDRA version 17.1 | Non-systematic Assessment |
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| Residual Urine Volume | Investigations | MedDRA version 17.1 | Systematic Assessment |
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| Bacteriuria | Infections and infestations | MedDRA version 17.1 | Systematic Assessment |
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| Leukocyturia | Renal and urinary disorders | MedDRA version 17.1 | Systematic Assessment |
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| Dysuria | Renal and urinary disorders | MedDRA version 17.1 | Systematic Assessment |
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| Haematuria | Renal and urinary disorders | MedDRA version 17.1 | Systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA version 17.1 | Non-systematic Assessment |
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| Nasopharyngitis | Infections and infestations | MedDRA version 17.1 | Non-systematic Assessment |
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| Renal Cyst | Renal and urinary disorders | MedDRA version 17.1 | Systematic Assessment |
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| Insomnia | Psychiatric disorders | MedDRA version 17.1 | Non-systematic Assessment |
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| Micturition Urgency | Renal and urinary disorders | MedDRA version 17.1 | Non-systematic Assessment |
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| Multiple Sclerosis Relapse | Nervous system disorders | MedDRA version 17.1 | Systematic Assessment |
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| Pollakiuria | Renal and urinary disorders | MedDRA version 17.1 | Non-systematic Assessment |
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| Urine Abnormality | Renal and urinary disorders | MedDRA version 17.1 | Systematic Assessment |
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| Urine Odour Abnormal | Renal and urinary disorders | MedDRA version 17.1 | Non-systematic Assessment |
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A disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 90 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Therapeutic Area Head, | Allergan, Inc | 714-246-4500 | clinicaltrials@allergan.com |
| ID | Term |
|---|---|
| D014549 | Urinary Incontinence |
| D009103 | Multiple Sclerosis |
| D001750 | Urinary Bladder, Neurogenic |
| ID | Term |
|---|---|
| D014555 | Urination Disorders |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D059411 | Lower Urinary Tract Symptoms |
| D020924 | Urological Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D003711 | Demyelinating Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D009461 | Neurologic Manifestations |
| D001745 | Urinary Bladder Diseases |
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| ID | Term |
|---|---|
| D019274 | Botulinum Toxins, Type A |
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D001905 | Botulinum Toxins |
| D008666 | Metalloendopeptidases |
| D010450 | Endopeptidases |
| D010447 | Peptide Hydrolases |
| D006867 | Hydrolases |
| D004798 | Enzymes |
| D045762 | Enzymes and Coenzymes |
| D045726 | Metalloproteases |
| D001426 | Bacterial Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D001427 | Bacterial Toxins |
| D014118 | Toxins, Biological |
| D001685 | Biological Factors |
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
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