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The purpose of this study is to assess the safety and effectiveness of botulinum toxin type A in treating overactive bladder in spinal cord injury or multiple sclerosis patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | botulinum toxin Type A (200U) |
|
| 2 | Experimental | botulinum toxin Type A (300U) |
|
| 3 | Other | placebo; botulinum toxin Type A (200U) |
|
| 4 | Other | placebo; botulinum toxin Type A (300U) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| botulinum toxin Type A (200U) | Biological | botulinum toxin Type A 200 U (tx 1) followed by botulinum toxin Type A 200 U (tx 2); injections into detrusor, at > 12 weeks interval |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Number of Weekly Episodes of Urinary Incontinence | Change from baseline in the weekly frequency of incontinence episodes at Week 6 after the first treatment. Incontinence is defined as involuntary loss of urine as recorded in a patient bladder diary. A negative number change from baseline indicates a reduction in incontinence episodes (improvement). | Baseline, Week 6 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Maximum Cystometric Capacity (MCC) | Change from baseline in MCC at week 6. MCC represents the maximum volume of urine the bladder holds. A positive number change from baseline represents an improvement (increase) in maximum volume of urine the bladder holds. | Baseline, Week 6 |
| Change From Baseline in Maximum Detrusor Pressure (MDP) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Allergan | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Royal Oak | Michigan | United States | ||||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25288099 | Derived | Cuervo J, Castejon N, Khalaf KM, Waweru C, Globe D, Patrick DL. Development of the Incontinence Utility Index: estimating population-based utilities associated with urinary problems from the Incontinence Quality of Life Questionnaire and Neurogenic Module. Health Qual Life Outcomes. 2014 Oct 8;12:147. doi: 10.1186/s12955-014-0147-7. | |
| 23892704 |
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| ID | Title | Description |
|---|---|---|
| FG000 | Botulinum Toxin Type A (300U) | botulinum toxin Type A (300U) |
| FG001 | Botulinum Toxin Type A (200U) | botulinum toxin Type A (200U) |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Treatment Cycle 1 |
|
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|
| botulinum toxin Type A (300U) | Biological | botulinum toxin Type A 300 U (tx 1) followed by botulinum toxin Type A 300 U (tx 2); injections into detrusor, at > 12 weeks interval |
|
|
| Normal Saline (Placebo); botulinum toxin Type A (200U) | Other | Placebo (tx 1) followed by botulinum toxin Type A 200 U (tx 2); injections into detrusor, at > 12 weeks interval |
|
|
| Normal Saline (Placebo); botulinum toxin Type A (300U) | Other | Placebo (tx 1) followed by botulinum toxin Type A 300 U (tx 2), injections into detrusor, at > 12 weeks interval |
|
|
Change from baseline in MDP during first involuntary detrusor contraction at week 6. MDP represents the maximum pressure (peak amplitude) in the bladder during the first involuntary contraction of the bladder muscle. The greater the negative number change from baseline, the better the improvement. |
| Baseline, Week 6 |
| Change From Baseline in Total Score on Incontinence Quality of Life (I-QOL) Questionnaire | Change from baseline in I-QOL questionnaire total score at Week 6, as completed by the patient. 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 | Baseline, Week 6 |
| Randwick |
| New South Wales |
| Australia |
| Innsbruck | Austria |
| Ghent | Belgium |
| Sherbrooke | Canada |
| Ostrava | Czechia |
| Garches | France |
| Halle | Germany |
| Christchurch | New Zealand |
| Wroclaw | Poland |
| Moscow | Russia |
| Martin | Slovakia |
| Lviv | Ukraine |
| London | United Kingdom |
| Chancellor MB, Patel V, Leng WW, Shenot PJ, Lam W, Globe DR, Loeb AL, Chapple CR. OnabotulinumtoxinA improves quality of life in patients with neurogenic detrusor overactivity. Neurology. 2013 Aug 27;81(9):841-8. doi: 10.1212/WNL.0b013e3182a2ca4d. Epub 2013 Jul 26. |
| 22503020 | Derived | Ginsberg D, Gousse A, Keppenne V, Sievert KD, Thompson C, Lam W, Brin MF, Jenkins B, Haag-Molkenteller C. Phase 3 efficacy and tolerability study of onabotulinumtoxinA for urinary incontinence from neurogenic detrusor overactivity. J Urol. 2012 Jun;187(6):2131-9. doi: 10.1016/j.juro.2012.01.125. Epub 2012 Apr 12. |
| FG002 | Placebo | Normal saline (placebo) |
| COMPLETED |
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| NOT COMPLETED |
|
| Treatment Cycle 2 |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Botulinum Toxin Type A (300U) | botulinum toxin Type A (300U) |
| BG001 | Botulinum Toxin Type A (200U) | botulinum toxin Type A (200U) |
| BG002 | Placebo | Normal saline (placebo) |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Number | participants |
| ||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
|
| 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 Number of Weekly Episodes of Urinary Incontinence | Change from baseline in the weekly frequency of incontinence episodes at Week 6 after the first treatment. Incontinence is defined as involuntary loss of urine as recorded in a patient bladder diary. A negative number change from baseline indicates a reduction in incontinence episodes (improvement). | Intent-to-Treat defined as all patients who started the study (randomized) | Posted | Mean | Standard Deviation | Number of Weekly Episodes | Baseline, Week 6 |
|
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| ||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Maximum Cystometric Capacity (MCC) | Change from baseline in MCC at week 6. MCC represents the maximum volume of urine the bladder holds. A positive number change from baseline represents an improvement (increase) in maximum volume of urine the bladder holds. | Intent-to-Treat defined as all patients who started the study (randomized) | Posted | Mean | Standard Deviation | Millimeters (mL) of urine | Baseline, Week 6 |
|
| |||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Maximum Detrusor Pressure (MDP) | Change from baseline in MDP during first involuntary detrusor contraction at week 6. MDP represents the maximum pressure (peak amplitude) in the bladder during the first involuntary contraction of the bladder muscle. The greater the negative number change from baseline, the better the improvement. | Intent-to-Treat defined as all patients who started the study (randomized) | Posted | Mean | Standard Deviation | Centimeters of water (cm H20) | Baseline, Week 6 |
|
| |||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Total Score on Incontinence Quality of Life (I-QOL) Questionnaire | Change from baseline in I-QOL questionnaire total score at Week 6, as completed by the patient. 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 | Intent-to-Treat defined as all patients who started the study (randomized) | Posted | Mean | Standard Deviation | Number on a Scale (Score) | Baseline, Week 6 |
|
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The safety population was used to calculate the number of participants at risk for SAEs and AEs and is the total number of patients that were randomized AND treated. S(AE)s are displayed for the placebo-controlled treatment Cycle 1.
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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 | Botulinum Toxin Type A (300U) | botulinum toxin Type A (300U) | 30 | 127 | 82 | 127 | ||
| EG001 | Botulinum Toxin Type A (200U) | botulinum toxin Type A (200U) | 24 | 135 | 92 | 135 | ||
| EG002 | Placebo | Normal saline (placebo) | 22 | 145 | 70 | 145 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Neutropenia | Blood and lymphatic system disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA (13.0) | Non-systematic Assessment |
| |
| Intestinal obstruction | Gastrointestinal disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Faecaloma | Gastrointestinal disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | MedDRA (13.0) | Non-systematic Assessment |
| |
| Adverse Drug Reaction | General disorders | MedDRA (13.0) | Systematic Assessment | Event not related to study drug, but to concomitant medication |
|
| Death | General disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA (13.0) | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA (13.0) | Systematic Assessment |
| |
| Bacteraemia | Infections and infestations | MedDRA (13.0) | Systematic Assessment |
| |
| Device related sepsis | Infections and infestations | MedDRA (13.0) | Systematic Assessment | Event related to central intravenous catheter |
|
| Pyelonephritis | Infections and infestations | MedDRA (13.0) | Systematic Assessment |
| |
| Staphylococcal bacteraemia | Infections and infestations | MedDRA (13.0) | Systematic Assessment |
| |
| Urinary tract infection bacterial | Infections and infestations | MedDRA (13.0) | Systematic Assessment |
| |
| Appendicitis | Infections and infestations | MedDRA (13.0) | Systematic Assessment |
| |
| Escherichia sepsis | Infections and infestations | MedDRA (13.0) | Systematic Assessment |
| |
| Central nervous system abscess | Infections and infestations | MedDRA (13.0) | Systematic Assessment |
| |
| Clostridium difficile colitis | Infections and infestations | MedDRA (13.0) | Systematic Assessment |
| |
| Cystitis | Infections and infestations | MedDRA (13.0) | Systematic Assessment |
| |
| Extradural abscess | Infections and infestations | MedDRA (13.0) | Systematic Assessment |
| |
| Osteomyelitis | Infections and infestations | MedDRA (13.0) | Systematic Assessment |
| |
| Osteomyelitis chronic | Infections and infestations | MedDRA (13.0) | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA (13.0) | Systematic Assessment |
| |
| Urosepsis | Infections and infestations | MedDRA (13.0) | Systematic Assessment |
| |
| Ankle fracture | Injury, poisoning and procedural complications | MedDRA (13.0) | Systematic Assessment |
| |
| Concussion | Injury, poisoning and procedural complications | MedDRA (13.0) | Systematic Assessment |
| |
| Eschar | Injury, poisoning and procedural complications | MedDRA (13.0) | Non-systematic Assessment |
| |
| Forearm fracture | Injury, poisoning and procedural complications | MedDRA (13.0) | Systematic Assessment |
| |
| Lower limb fracture | Injury, poisoning and procedural complications | MedDRA (13.0) | Systematic Assessment |
| |
| Tendon rupture | Injury, poisoning and procedural complications | MedDRA (13.0) | Systematic Assessment |
| |
| Thermal burn | Injury, poisoning and procedural complications | MedDRA (13.0) | Non-systematic Assessment |
| |
| Oxygen saturation decreased | Investigations | MedDRA (13.0) | Systematic Assessment |
| |
| Obesity | Metabolism and nutrition disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Intervertebral disc protrusion | Musculoskeletal and connective tissue disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Spondylolisthesis | Musculoskeletal and connective tissue disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Vertebral foraminal stenosis | Musculoskeletal and connective tissue disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Basal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (13.0) | Systematic Assessment |
| |
| Breast cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (13.0) | Systematic Assessment |
| |
| Multiple sclerosis relapse | Nervous system disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Epilepsy | Nervous system disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Metabolic encephalopathy | Nervous system disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Mental status changes | Psychiatric disorders | MedDRA (13.0) | Systematic Assessment | Event not related to study medication; related to underlying adverse event of urinary tract infection |
|
| Calculus ureteric | Renal and urinary disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Urinary retention | Renal and urinary disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Hydronephrosis | Renal and urinary disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Stress urinary incontinence | Renal and urinary disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Renal failure chronic | Renal and urinary disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Epididymitis | Reproductive system and breast disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Decubitus ulcer | Skin and subcutaneous tissue disorders | MedDRA (13.0) | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | MedDRA (13.0) | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA (13.0) | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA (13.0) | Non-systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA (13.0) | Systematic Assessment |
| |
| Vulvovaginal mycotic infection | Infections and infestations | MedDRA (13.0) | Systematic Assessment | Percentages for this adverse event were calculated based on the number of female patients in each group |
|
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA (13.0) | Non-systematic Assessment |
| |
| Multiple sclerosis relapse | Nervous system disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (13.0) | Non-systematic Assessment |
| |
| Urinary retention | Renal and urinary disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Bladder pain | Renal and urinary disorders | MedDRA (13.0) | Non-systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA (13.0) | Systematic Assessment |
|
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 |
|---|---|
| D053201 | Urinary Bladder, Overactive |
| ID | Term |
|---|---|
| D001745 | Urinary Bladder Diseases |
| 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 |
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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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| Between 40 and 64 years |
|
| Between 65 and 74 years |
|
| >=75 years |
|
| Male |
|
|
|
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
|