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| ID | Type | Description | Link |
|---|---|---|---|
| 2015-000507-44 | EudraCT Number |
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Slow recruitment of patients
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The purpose of this study is to provide confirmatory evidence of the safety and efficacy of two Dysport® 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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 600 U Dysport® Group | Experimental |
| |
| 600 U Dysport® Placebo Group | Placebo Comparator |
| |
| 800 U Dysport® Group | Experimental |
| |
| 800 U Dysport® Placebo Group | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Botulinum toxin type A | Biological | 600 U intra detrusor injection in two treatment periods (Initial and Retreatment phase) delivered at 30 injection points. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mean Change From Baseline in Weekly Number of UI Episodes at Week 6 of DBPC Cycle | The weekly number of UI episodes was measured using a 7-day bladder diary. Bladder diaries that contained data recorded on at least 5 days were included in the analysis. The least square (LS) mean of the change in weekly number of UI episodes at 6 weeks after the first study treatment was calculated using a mixed model repeated measures (MMRM) analysis. | Baseline and Week 6 of DBPC Cycle |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Subjects With No Episodes of UI at Week 6 of DBPC Cycle | The weekly number of UI episodes was measured using a 7-day bladder diary. Bladder diaries that contained data recorded on at least 5 days were included in the analysis. The number of subjects with no UI episodes at 6 weeks after the first study treatment was recorded. Percentage of subjects with no episodes of UI (≥100% Improvement) was calculated as: Total number of subjects with no weekly number of UI episodes at Week 6 / Total number of subjects with any number of UI events at Week 6. |
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Key Inclusion Criteria:
Key Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ipsen Medical Director | Ipsen | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Instituto Urológico Buenos Aires | Buenos Aires | 1060 | Argentina | |||
| Centro de Urologia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35400537 | Derived | Kennelly M, Cruz F, Herschorn S, Abrams P, Onem K, Solomonov VK, Del Rosario Figueroa Coz E, Manu-Marin A, Giannantoni A, Thompson C, Vilain C, Volteau M, Denys P; Dysport CONTENT Program Group. Efficacy and Safety of AbobotulinumtoxinA in Patients with Neurogenic Detrusor Overactivity Incontinence Performing Regular Clean Intermittent Catheterization: Pooled Results from Two Phase 3 Randomized Studies (CONTENT1 and CONTENT2). Eur Urol. 2022 Aug;82(2):223-232. doi: 10.1016/j.eururo.2022.03.010. Epub 2022 Apr 7. |
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Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, annotated case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized, and study documents will be redacted to protect the privacy of study participants.
Any requests should be submitted to www.vivli.org for assessment by an independent scientific review board.
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Where applicable, data from eligible studies are available 6 months after the studied medicine and indication have been approved in the US and EU or after the primary manuscript describing the results has been accepted for publication, whichever is later.
Further details on Ipsen's sharing criteria, eligible studies and process for sharing are available here (https://vivli.org/members/ourmembers/).
Subjects were randomised to 1 of 4 sequences: A) placebo in a double-blind placebo-controlled (DBPC) cycle then Dysport® 600 Units (U) in subsequent double-blind cycles: B) placebo in DBPC cycle then Dysport® 800 U in subsequent cycles: C) Dysport® 600 U in all cycles: D) Dysport® 800 U in all cycles. The minimum retreatment interval was 12 weeks.
A total of 258 subjects with urinary incontinence (UI) caused by neurogenic detrusor overactivity (NDO) due to spinal cord injury (SCI) or multiple sclerosis (MS) were enrolled at 67 study sites worldwide. One of the 258 randomised subjects did not receive any treatment. The study was terminated early by the sponsor due to lack of recruitment.
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Subjects were administered placebo on Day 1 of the DBPC cycle. All study treatments were injected into the detrusor muscle via cystoscopy in a total volume of 15 millilitres (mL) divided into 30 injection points of 0.5 mL each. Subjects were followed-up by telephone at Week 1 and Week 4; and attended clinic visits at Week 2, Week 6 (primary study timepoint), and Week 12. Thereafter telephone visits were scheduled every 12 weeks until end of study, or until retreatment was required. |
| Title | Milestones | Reasons Not Completed | ||||
|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Apr 16, 2018 | Jul 6, 2020 |
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|
| Botulinum toxin type A | Biological | 800 U intra detrusor injection in two treatment periods (Initial and Retreatment phase) delivered at 30 injection points |
|
|
| Placebo | Drug | AbobotulinumtoxinA Placebo 600 U intra detrusor injection in two treatment periods (Initial and Retreatment phase) delivered at 30 injection points |
|
| Placebo | Drug | AbobotulinumtoxinA Placebo 800 U intra detrusor injection in two treatment periods (Initial and Retreatment phase) delivered at 30 injection points |
|
| Baseline and Week 6 of DBPC Cycle |
| Percentage of Subjects With a UI Response at Improvement Levels ≥30%, ≥50%, and ≥75% at Week 6 of the DBPC Cycle | The weekly number of UI episodes was measured using a 7-day bladder diary. Bladder diaries that contained data recorded on at least 5 days were included in the analysis. The percentage of subjects showing an improvement of ≥30%, ≥50% and ≥75% was calculated as: Total number of subjects with UI response level >=30% or >=50% or >=75% improvement at Week 6 / Total number of subjects with any UI response at Week 6. | Baseline and Week 6 of DBPC Cycle |
| Median Time Between Treatments | Duration of effect for time between treatments was calculated by: (the date of the first retreatment visit - date of first treatment administration in the DBPC cycle). The median number of days between treatments was determined and subjects with no retreatment were censored at the last visit. | Day of first treatment (baseline) to day of retreatment, up to 2 years |
| Mean Change From Baseline in Volume Per Void at Week 6 of DBPC Cycle | The volume per void was measured during one 24-hour period of the 7-day bladder diary. The LS mean of the change in volume per void at 6 weeks after the first study treatment was calculated using a MMRM analysis. | Baseline and Week 6 of DBPC Cycle |
| Mean Change From Baseline in Maximum Cystometric Capacity (MCC) at Week 6 of DBPC Cycle | Subjects included in the urodynamic subset (84.9% of randomised subjects) had a standardised urodynamic filling cystometry assessment at baseline (Screening) and again at Week 6 to determine the MCC. The LS mean of the change in MCC at 6 weeks after the first study treatment was calculated using an analysis of covariance (ANCOVA). | Baseline and Week 6 of DBPC Cycle |
| Mean Change From Baseline in Maximum Detrusor Pressure (MDP) During Storage at Week 6 of DBPC Cycle | Subjects included in the urodynamic subset (84.9% of randomised subjects) had a standardised urodynamic filling cystometry assessment at baseline (Screening) and again at Week 6 to determine the MDP. The LS mean of the change in MDP at 6 weeks after the first study treatment was calculated using an ANCOVA. | Baseline and Week 6 of DBPC Cycle |
| Mean Change From Baseline in Volume at First Involuntary Detrusor Contraction (Vol@1stIDC) at Week 6 of DBPC Cycle | Subjects included in the urodynamic subset (84.9% of randomised subjects) had a standardised urodynamic filling cystometry assessment at baseline (Screening) and again at Week 6 to determine the Vol@1stIDC which is the instilled volume when first IDC commences. Subjects who did not exhibit a post-treatment IDC at Week 6 had Vol@1stIDC imputed using the recorded corrected MCC volume at Week 6. The LS mean of the change in Vol@1stIDC at 6 weeks after the first study treatment was calculated using an ANCOVA. | Baseline and Week 6 of DBPC Cycle |
| Percentage of Subjects With No Involuntary Detrusor Contraction (IDCs) During Storage at Week 6 of DBPC Cycle | Subjects included in the urodynamic subset (84.9% of randomised subjects) had a standardised urodynamic filling cystometry assessment at baseline (Screening) and again at Week 6 to determine the occurrence of IDCs. The percentage of subjects without IDCs at 6 weeks after the first study treatment was recorded. | Baseline and Week 6 of DBPC Cycle |
| Buenos Aires |
| C1120AAS |
| Argentina |
| Centro Urológico Profesor Bengió | Córdoba | X5000 | Argentina |
| Hospital Privado - Centro Médico de Córdoba | Córdoba | X5016KEH | Argentina |
| Instituto Médico Rodriguez Alfici | Godoy Cruz | M5501AAP | Argentina |
| Prince of Wales Hospital (POWH) | Sydney | 2031 | Australia |
| Westmead Hospital | Westmead | 2145 | Australia |
| Antwerp University hospital | Antwerp | Belgium |
| Hôpital Erasme | Brussels | 1070 | Belgium |
| Ourthe-Amblève | Esneux | 4130 | Belgium |
| Universidade Estadual de Campinas - Cidade Universitária Zeferino Vaz | Campinas | 13083-970 | Brazil |
| Hospital de Clinicas, Federal University of Paraná | Curitiba | 80060-900 | Brazil |
| Hospital São Vicente de Paulo | Passo Fundo | 99010-080 | Brazil |
| Santa Casa de Misericórdia de Porto Alegre - Hospital Santa Clara | Porto Alegre | 90020-090 | Brazil |
| Hospital Moinhos de Vento | Pôrto Alegre | 90560-030 | Brazil |
| Hospital São Lucas da PUCRS | Pôrto Alegre | 90610-000 | Brazil |
| Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto da Universidade de São Paulo | Ribeirão Preto | 14048-900 | Brazil |
| Faculdade de Medicina do ABC | Santo André | 09060-650 | Brazil |
| Hospital Alemão Oswaldo Cruz | São Paulo | 01323-020 | Brazil |
| Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo | São Paulo | 05422-970 | Brazil |
| Clínica Uromed | Santiago | 7500787 | Chile |
| Hospital del Trabajador | Santiago | 7501241 | Chile |
| Clínica Las Condes | Santiago | 7591046 | Chile |
| Solano & Terront Servicios Medicos LTDA- Unidad Integral de Endocrinologia | Bogotá | 110221 | Colombia |
| Fundación Valle del Lili | Cali | 760032 | Colombia |
| Centro Medico Imbanaco | Cali | 760042 | Colombia |
| Asociacion IPS Medicos Internistas de Caldas | Manizales | 170004 | Colombia |
| Centro de Investigaciones Clinicas - CIC | Medellín | 5001000 | Colombia |
| Hôpital Raymond-Poincaré | Garches | France |
| Centre Hospitalier Régional Universitaire de Lille (CHRU) - Hôpital Claude Huriez | Lille | France |
| Hôpital de la Conception | Marseille | France |
| Groupe Hospitalo-Universitaire Pierre Caremau | Nîmes | France |
| Hopital de la Source | Orléans | France |
| Hopital Pitie-Salpetriere | Paris | France |
| Hôpital Tenon | Paris | France |
| Centre Hospitalier Lyon-Sud | Pierre-Bénite | France |
| CHU de Rennes - Hôpital Pontchaillou | Rennes | France |
| CHU de ROUEN - Hôpital Charles Nicolle | Rouen | France |
| Hôpital Rangueil | Toulouse | France |
| Universitätsklinikum Bonn Klinik und Poliklinik für Urologie | Bonn | 53127 | Germany |
| Kliniken Maria Hilf GmbH - Krankenhaus St. Franziskus | Mönchengladbach | Germany |
| Universitätsklinikum Münster | Münster | 48149 | Germany |
| Rambam Medical Center | Haifa | 31096 | Israel |
| Carmel Medical Center | Haifa | 34362 | Israel |
| Meir Medical Center | Kfar Saba | 44281 | Israel |
| Rabin Medical Center - Davidoff Center | Petah Tikva | 49100 | Israel |
| The Chaim Sheba Medical Center | Ramat Gan | 52621 | Israel |
| Estetines Chirurgijos Centas, UAB | Kaunas | 49476 | Lithuania |
| Vilnius University Hospital Santariskiu Klinikos | Vilnius | 8661 | Lithuania |
| Centro Medico Puerta de Hierro - Colima | Colima | 28018 | Mexico |
| Clinstile, S.A. de C.V. | Cuauhtémoc | 06700 | Mexico |
| Hospital Universitario "Dr. José Eleuterio González" | Monterrey | 64460 | Mexico |
| Consultorio Privado | Zapopan | 45040 | Mexico |
| Clínica San Pablo Surco | Lima | 15023 | Peru |
| Clinica Good Hope | Lima | Lima18 | Peru |
| Clinica Internacional Sede Lima | Lima | Lima1 | Peru |
| Clínica Anglo Americana | Lima | Lima27 | Peru |
| Instituto de Ginecología y Reproducción | Lima | Lima33 | Peru |
| Unidad de Investigación de la Clínica Internacional Sede San Borja | Lima | Lima41 | Peru |
| Scientific research institute of urology and interventional radiology n. a. N. A. Lopatkin | Moscow | 105425 | Russia |
| Ministry of healthcare of the Russian Federation | Moscow | 129226 | Russia |
| Penza Regional Clinical Hospital n.a. N.N.Burdenko | Penza | 440026 | Russia |
| Rostov State Medical University | Rostov-on-Don | 344022 | Russia |
| St. Petersburg Research Institute of Phthisiopulmonology | Saint Petersburg | 194064 | Russia |
| Pavlov First Saint Petersburg State Medical University | Saint Petersburg | 197089 | Russia |
| City Hospital No. 40 | Saint Petersburg | 197706 | Russia |
| Hospital Orkli | Saint Petersburg | Russia |
| Complexo Hospitalario Universitario A Coruña | A Coruña | Spain |
| Fundacio Puigvert | Barcelona | 08025 | Spain |
| Fundació GAEM | Barcelona | Spain |
| Hospital Universitario Vall d'Hebron | Barcelona | Spain |
| Hospital Universitario La Paz | Madrid | Spain |
| Hospital Universitario Virgen del Rocío | Seville | Spain |
| Hospital Universitari i Politècnic La Fe | Valencia | Spain |
| Municipal Healthcare Institution "Regional Clinical Center of Urology and Nephrology n.a. V.I. Shapoval", Urology Department | Kharkiv | 61037 | Ukraine |
| Kiev City Clinical Hospital No. 3 | Kiev | 02125 | Ukraine |
| NHS Grampian - Aberdeen Royal Infirmary | Aberdeen | AB25 2ZN | United Kingdom |
| Bedford Hospital | Bedford | MK42 9DJ | United Kingdom |
| National Hospital for Neurology and Neurosurgery - UCL | London | WC1N 3BG | United Kingdom |
| Sheffield Teaching Hospitals NHS Foundation Trust - Royal Hallamshire Hospital | Sheffield | S10 2JF | United Kingdom |
| Royal National Orthopaedic Hospital Trust | Stanmore | HA7 4LP | United Kingdom |
| The Mid Yorkshire Hospitals NHS Trust - Pinderfields Hospital | Wakefield | WF1 4DG | United Kingdom |
| FG001 | Dysport® 600 U | Subjects were administered Dysport® 600 U on Day 1 of the DBPC cycle. All study treatments were injected into the detrusor muscle via cystoscopy in a total volume of 15 mL divided into 30 injection points of 0.5 mL each. Subjects were followed-up by telephone at Week 1 and Week 4; and attended clinic visits at Week 2, Week 6 (primary study timepoint), and Week 12. Thereafter telephone visits were scheduled every 12 weeks until end of study, or until retreatment was required. |
| FG002 | Dysport® 800 U | Subjects were administered Dysport® 800 U on Day 1 of the DBPC cycle. All study treatments were injected into the detrusor muscle via cystoscopy in a total volume of 15 mL divided into 30 injection points of 0.5 mL each. Subjects were followed-up by telephone at Week 1 and Week 4; and attended clinic visits at Week 2, Week 6 (primary study timepoint), and Week 12. Thereafter telephone visits were scheduled every 12 weeks until end of study, or until retreatment was required. |
|
| Subjects Entered in the Dysport Cycles |
|
| COMPLETED | Subjects completed the study in the Dysport cycles |
|
| NOT COMPLETED |
|
|
Modified intention to treat (mITT) population: All randomised subjects who received at least 1 administration of study treatment. Subjects were analysed as randomised (planned treatment).
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Subjects were administered placebo on Day 1 of the DBPC cycle. All study treatments were injected into the detrusor muscle via cystoscopy in a total volume of 15 mL divided into 30 injection points of 0.5 mL each. Subjects were followed-up by telephone at Week 1 and Week 4; and attended clinic visits at Week 2, Week 6 (primary study timepoint), and Week 12. Thereafter telephone visits were scheduled every 12 weeks until end of study, or until retreatment was required. |
| BG001 | Dysport® 600 U | Subjects were administered Dysport® 600 U on Day 1 of the DBPC cycle. All study treatments were injected into the detrusor muscle via cystoscopy in a total volume of 15 mL divided into 30 injection points of 0.5 mL each. Subjects were followed-up by telephone at Week 1 and Week 4; and attended clinic visits at Week 2, Week 6 (primary study timepoint), and Week 12. Thereafter telephone visits were scheduled every 12 weeks until end of study, or until retreatment was required. |
| BG002 | Dysport® 800 U | Subjects were administered Dysport® 800 U on Day 1 of the DBPC cycle. All study treatments were injected into the detrusor muscle via cystoscopy in a total volume of 15 mL divided into 30 injection points of 0.5 mL each. Subjects were followed-up by telephone at Week 1 and Week 4; and attended clinic visits at Week 2, Week 6 (primary study timepoint), and Week 12. Thereafter telephone visits were scheduled every 12 weeks until end of study, or until retreatment was required. |
| 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, Categorical | Count of Participants | Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Aetiology of NDO | 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 | Mean Change From Baseline in Weekly Number of UI Episodes at Week 6 of DBPC Cycle | The weekly number of UI episodes was measured using a 7-day bladder diary. Bladder diaries that contained data recorded on at least 5 days were included in the analysis. The least square (LS) mean of the change in weekly number of UI episodes at 6 weeks after the first study treatment was calculated using a mixed model repeated measures (MMRM) analysis. | Results are presented for the mITT population (all randomised subjects who received at least 1 administration of study treatment). Subjects were analysed as randomised (planned treatment). Only subjects with data available for analysis at Week 6 of DBPC cycle are presented. | Posted | Least Squares Mean | Standard Error | Weekly UI episodes | Baseline and Week 6 of DBPC Cycle |
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| Secondary | Percentage of Subjects With No Episodes of UI at Week 6 of DBPC Cycle | The weekly number of UI episodes was measured using a 7-day bladder diary. Bladder diaries that contained data recorded on at least 5 days were included in the analysis. The number of subjects with no UI episodes at 6 weeks after the first study treatment was recorded. Percentage of subjects with no episodes of UI (≥100% Improvement) was calculated as: Total number of subjects with no weekly number of UI episodes at Week 6 / Total number of subjects with any number of UI events at Week 6. | Results are presented for the mITT population (all randomised subjects who received at least 1 administration of study treatment). Subjects were analysed as randomised (planned treatment). Only subjects with data available for analysis at Week 6 of DBPC cycle are presented. | Posted | Number | Percentage of Subjects | Baseline and Week 6 of DBPC Cycle |
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| Secondary | Percentage of Subjects With a UI Response at Improvement Levels ≥30%, ≥50%, and ≥75% at Week 6 of the DBPC Cycle | The weekly number of UI episodes was measured using a 7-day bladder diary. Bladder diaries that contained data recorded on at least 5 days were included in the analysis. The percentage of subjects showing an improvement of ≥30%, ≥50% and ≥75% was calculated as: Total number of subjects with UI response level >=30% or >=50% or >=75% improvement at Week 6 / Total number of subjects with any UI response at Week 6. | Results are presented for the mITT population (all randomised subjects who received at least 1 administration of study treatment). Subjects were analysed as randomised (planned treatment). Only subjects with data available for analysis at Week 6 of DBPC cycle are presented. | Posted | Number | Percentage of Subjects | Baseline and Week 6 of DBPC Cycle |
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| Secondary | Median Time Between Treatments | Duration of effect for time between treatments was calculated by: (the date of the first retreatment visit - date of first treatment administration in the DBPC cycle). The median number of days between treatments was determined and subjects with no retreatment were censored at the last visit. | Results are presented for the mITT population (all randomised subjects who received at least 1 administration of study treatment). Subjects were analysed as randomised (planned treatment). | Posted | Median | Full Range | Days | Day of first treatment (baseline) to day of retreatment, up to 2 years |
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| Secondary | Mean Change From Baseline in Volume Per Void at Week 6 of DBPC Cycle | The volume per void was measured during one 24-hour period of the 7-day bladder diary. The LS mean of the change in volume per void at 6 weeks after the first study treatment was calculated using a MMRM analysis. | Results are presented for the mITT population (all randomised subjects who received at least 1 administration of study treatment). Subjects were analysed as randomised (planned treatment). Only subjects with data available for analysis at Week 6 of DBPC cycle are presented. | Posted | Least Squares Mean | Standard Error | mL | Baseline and Week 6 of DBPC Cycle |
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| Secondary | Mean Change From Baseline in Maximum Cystometric Capacity (MCC) at Week 6 of DBPC Cycle | Subjects included in the urodynamic subset (84.9% of randomised subjects) had a standardised urodynamic filling cystometry assessment at baseline (Screening) and again at Week 6 to determine the MCC. The LS mean of the change in MCC at 6 weeks after the first study treatment was calculated using an analysis of covariance (ANCOVA). | Results are presented for the urodynamic population (all subjects in the mITT population included in the urodynamic subset at randomisation). Subjects were analysed as randomised (planned treatment). Only subjects with data available for analysis at Week 6 of DBPC cycle are presented. | Posted | Least Squares Mean | Standard Error | mL | Baseline and Week 6 of DBPC Cycle |
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| Secondary | Mean Change From Baseline in Maximum Detrusor Pressure (MDP) During Storage at Week 6 of DBPC Cycle | Subjects included in the urodynamic subset (84.9% of randomised subjects) had a standardised urodynamic filling cystometry assessment at baseline (Screening) and again at Week 6 to determine the MDP. The LS mean of the change in MDP at 6 weeks after the first study treatment was calculated using an ANCOVA. | Results are presented for the urodynamic population (all subjects in the mITT population included in the urodynamic subset at randomisation). Subjects were analysed as randomised (planned treatment). Only subjects with data available for analysis at Week 6 of DBPC cycle are presented. | Posted | Least Squares Mean | Standard Error | centimetres of water | Baseline and Week 6 of DBPC Cycle |
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| Secondary | Mean Change From Baseline in Volume at First Involuntary Detrusor Contraction (Vol@1stIDC) at Week 6 of DBPC Cycle | Subjects included in the urodynamic subset (84.9% of randomised subjects) had a standardised urodynamic filling cystometry assessment at baseline (Screening) and again at Week 6 to determine the Vol@1stIDC which is the instilled volume when first IDC commences. Subjects who did not exhibit a post-treatment IDC at Week 6 had Vol@1stIDC imputed using the recorded corrected MCC volume at Week 6. The LS mean of the change in Vol@1stIDC at 6 weeks after the first study treatment was calculated using an ANCOVA. | Results are presented for the urodynamic population (all subjects in the mITT population included in the urodynamic subset at randomisation). Subjects were analysed as randomised (planned treatment). Only subjects with data available for analysis at Week 6 of DBPC cycle are presented. | Posted | Least Squares Mean | Standard Error | mL | Baseline and Week 6 of DBPC Cycle |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Subjects With No Involuntary Detrusor Contraction (IDCs) During Storage at Week 6 of DBPC Cycle | Subjects included in the urodynamic subset (84.9% of randomised subjects) had a standardised urodynamic filling cystometry assessment at baseline (Screening) and again at Week 6 to determine the occurrence of IDCs. The percentage of subjects without IDCs at 6 weeks after the first study treatment was recorded. | Results are presented for the urodynamic population (all subjects in the mITT population included in the urodynamic subset at randomisation). Subjects were analysed as randomised (planned treatment). Only subjects with data available for analysis at Week 6 of DBPC cycle are presented. | Posted | Number | Percentage of Subjects | Baseline and Week 6 of DBPC Cycle |
|
Treatment emergent adverse events are presented for the full DBPC cycle (i.e. approximately 32 weeks for both Dysport® groups and approximately 19 weeks for the Placebo group).
The safety population included all subjects who received at least 1 administration of study treatment (including only partial administration). Safety subjects were analysed according to their actual treatment received. One subject randomised to placebo received Dysport 600 U, and 1 subject randomised to Dysport 800 U did not receive treatment and was not included in the safety population. Number of deaths (all causes) is presented for the duration of the study (up to a maximum of 115 weeks).
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo | Subjects were administered placebo on Day 1 of the DBPC cycle. All study treatments were injected into the detrusor muscle via cystoscopy in a total volume of 15 mL divided into 30 injection points of 0.5 mL each. Subjects were followed-up by telephone at Week 1 and Week 4; and attended clinic visits at Week 2, Week 6 (primary study timepoint), and Week 12. Thereafter telephone visits were scheduled every 12 weeks until end of study, or until retreatment was required. | 0 | 85 | 0 | 85 | 34 | 85 |
| EG001 | Dysport® 600 U | Subjects were administered Dysport® 600 U on Day 1 of the DBPC cycle. All study treatments were injected into the detrusor muscle via cystoscopy in a total volume of 15 mL divided into 30 injection points of 0.5 mL each. Subjects were followed-up by telephone at Week 1 and Week 4; and attended clinic visits at Week 2, Week 6 (primary study timepoint), and Week 12. Thereafter telephone visits were scheduled every 12 weeks until end of study, or until retreatment was required. | 1 | 87 | 9 | 87 | 40 | 87 |
| EG002 | Dysport® 800 U | Subjects were administered Dysport® 800 U on Day 1 of the DBPC cycle. All study treatments were injected into the detrusor muscle via cystoscopy in a total volume of 15 mL divided into 30 injection points of 0.5 mL each. Subjects were followed-up by telephone at Week 1 and Week 4; and attended clinic visits at Week 2, Week 6 (primary study timepoint), and Week 12. Thereafter telephone visits were scheduled every 12 weeks until end of study, or until retreatment was required. | 0 | 85 | 8 | 85 | 42 | 85 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Femur fracture | Injury, poisoning and procedural complications | MedDRA 22.0 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Cerebrovascular accident | Nervous system disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Multiple sclerosis relapse | Nervous system disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Ataxia | Nervous system disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Multiple sclerosis | Nervous system disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Gait disturbance | General disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
| |
| Diverticulitis | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
| |
| Osteomyelitis | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
| |
| Osteomyelitis chronic | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
| |
| Perineal abscess | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
| |
| Soft tissue infection | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
| |
| Testicular abscess | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
| |
| Urosepsis | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
| |
| Orchitis | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Haemorrhage | Vascular disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Anaesthetic complication cardiac | Injury, poisoning and procedural complications | MedDRA 22.0 | Systematic Assessment |
| |
| Nitrite urine present | Investigations | MedDRA 22.0 | Systematic Assessment |
| |
| Blood urine present | Investigations | MedDRA 22.0 | Systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Muscle spasticity | Nervous system disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Neuralgia | Nervous system disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Malaise | General disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Abdominal pain lower | Gastrointestinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Erectile dysfunction | Reproductive system and breast disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Leukocyturia | Renal and urinary disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
| |
| Bacteriuria | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
| |
| Pharyngitis | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
| |
| Bladder pain | Renal and urinary disorders | MedDRA 22.0 | Systematic Assessment |
|
This study was terminated early by the sponsor on 04 October 2018, due to slow subject recruitment (258 subjects randomised compared to 330 planned subjects). Only primary and key secondary efficacy analyses were performed.
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Director | Ipsen | See email | clinical.trials@ipsen.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Sep 21, 2018 | Jul 6, 2020 | SAP_001.pdf |
| ID | Term |
|---|---|
| D014549 | Urinary Incontinence |
| D053201 | Urinary Bladder, Overactive |
| 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 |
| D001745 | Urinary Bladder Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D019274 | Botulinum Toxins, Type A |
| C542869 | abobotulinumtoxinA |
| 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 |
Not provided
Not provided
| Between 18 and 65 years |
|
| >=65 years |
|
| Male |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| MS |
|
| Treatment group, visit (Week 6), treatment-by-visit interaction, recorded stratification factors (aetiology of NDO [SCI or MS], prior intradetrusor [Botulinum toxin [BTX]-naïve or BTX-non-naïve]) and study baseline value (weekly number of UI episodes) as fixed effect variables, and subject as a random effect. | MMLM | <0.0001 | LS Mean Difference | -9.76 | 2-Sided | 95 | -14.41 | -5.12 | Superiority | If both p-values for the 2 primary tests (the test of Dysport® 800 U vs. placebo and the test of Dysport® 600 U vs. placebo) were lower than 0.05, both were declared statistically significant. If 1 of the primary tests had a p-value greater than or equal to 0.05, then the other test was declared statistically significant if its p-value was lower than 0.025 and only the significant dose continued in the hierarchal testing strategy. |
| OG002 | Dysport® 800 U | Subjects were administered Dysport® 800 U on Day 1 of the DBPC cycle. All study treatments were injected into the detrusor muscle via cystoscopy in a total volume of 15 mL divided into 30 injection points of 0.5 mL each. Subjects were followed-up by telephone at Week 1 and Week 4; and attended clinic visits at Week 2, Week 6 (primary study timepoint), and Week 12. Thereafter telephone visits were scheduled every 12 weeks until end of study, or until retreatment was required. |
|
|
|
| OG002 | Dysport® 800 U | Subjects were administered Dysport® 800 U on Day 1 of the DBPC cycle. All study treatments were injected into the detrusor muscle via cystoscopy in a total volume of 15 mL divided into 30 injection points of 0.5 mL each. Subjects were followed-up by telephone at Week 1 and Week 4; and attended clinic visits at Week 2, Week 6 (primary study timepoint), and Week 12. Thereafter telephone visits were scheduled every 12 weeks until end of study, or until retreatment was required. |
|
|
|
| OG002 | Dysport® 800 U | Subjects were administered Dysport® 800 U on Day 1 of the DBPC cycle. All study treatments were injected into the detrusor muscle via cystoscopy in a total volume of 15 mL divided into 30 injection points of 0.5 mL each. Subjects were followed-up by telephone at Week 1 and Week 4; and attended clinic visits at Week 2, Week 6 (primary study timepoint), and Week 12. Thereafter telephone visits were scheduled every 12 weeks until end of study, or until retreatment was required. |
|
|
| OG002 | Dysport® 800 U | Subjects were administered Dysport® 800 U on Day 1 of the DBPC cycle. All study treatments were injected into the detrusor muscle via cystoscopy in a total volume of 15 mL divided into 30 injection points of 0.5 mL each. Subjects were followed-up by telephone at Week 1 and Week 4; and attended clinic visits at Week 2, Week 6 (primary study timepoint), and Week 12. Thereafter telephone visits were scheduled every 12 weeks until end of study, or until retreatment was required. |
|
|
|
| OG002 | Dysport® 800 U | Subjects were administered Dysport® 800 U on Day 1 of the DBPC cycle. All study treatments were injected into the detrusor muscle via cystoscopy in a total volume of 15 mL divided into 30 injection points of 0.5 mL each. Subjects were followed-up by telephone at Week 1 and Week 4; and attended clinic visits at Week 2, Week 6 (primary study timepoint), and Week 12. Thereafter telephone visits were scheduled every 12 weeks until end of study, or until retreatment was required. |
|
|
|
| OG002 | Dysport® 800 U | Subjects were administered Dysport® 800 U on Day 1 of the DBPC cycle. All study treatments were injected into the detrusor muscle via cystoscopy in a total volume of 15 mL divided into 30 injection points of 0.5 mL each. Subjects were followed-up by telephone at Week 1 and Week 4; and attended clinic visits at Week 2, Week 6 (primary study timepoint), and Week 12. Thereafter telephone visits were scheduled every 12 weeks until end of study, or until retreatment was required. |
|
|
|
Subjects were administered Dysport® 600 U on Day 1 of the DBPC cycle. All study treatments were injected into the detrusor muscle via cystoscopy in a total volume of 15 mL divided into 30 injection points of 0.5 mL each. Subjects were followed-up by telephone at Week 1 and Week 4; and attended clinic visits at Week 2, Week 6 (primary study timepoint), and Week 12. Thereafter telephone visits were scheduled every 12 weeks until end of study, or until retreatment was required. |
| OG002 | Dysport® 800 U | Subjects were administered Dysport® 800 U on Day 1 of the DBPC cycle. All study treatments were injected into the detrusor muscle via cystoscopy in a total volume of 15 mL divided into 30 injection points of 0.5 mL each. Subjects were followed-up by telephone at Week 1 and Week 4; and attended clinic visits at Week 2, Week 6 (primary study timepoint), and Week 12. Thereafter telephone visits were scheduled every 12 weeks until end of study, or until retreatment was required. |
|
|
|
| OG002 | Dysport® 800 U | Subjects were administered Dysport® 800 U on Day 1 of the DBPC cycle. All study treatments were injected into the detrusor muscle via cystoscopy in a total volume of 15 mL divided into 30 injection points of 0.5 mL each. Subjects were followed-up by telephone at Week 1 and Week 4; and attended clinic visits at Week 2, Week 6 (primary study timepoint), and Week 12. Thereafter telephone visits were scheduled every 12 weeks until end of study, or until retreatment was required. |
|
|
|