Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 8 of 647 for:    Russian Federation | Chile

Dysport® Treatment of Urinary Incontinence in Adults Subjects With Neurogenic Detrusor Overactivity (NDO) Due to Spinal Cord Injury or Multiple Sclerosis - Study 2 (CONTENT2)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02660359
Recruitment Status : Terminated (Low recruitment of patients)
First Posted : January 21, 2016
Last Update Posted : September 16, 2019
Sponsor:
Information provided by (Responsible Party):
Ipsen

Brief Summary:
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).

Condition or disease Intervention/treatment Phase
Urinary Incontinence Overactive Bladder Biological: Botulinum toxin type A Drug: Placebo Phase 3

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 258 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
Actual Study Start Date : July 8, 2016
Actual Primary Completion Date : November 9, 2018
Actual Study Completion Date : July 4, 2019


Arm Intervention/treatment
Experimental: 600 U Dysport® Group Biological: Botulinum toxin type A
600 U intra detrusor injection in two treatment periods (Initial and Retreatment phase) delivered at 30 injection points.
Other Names:
  • AbobotulinumtoxinA (Dysport®)
  • Clostridium BTX-A-haemagglutinin complex

Placebo Comparator: 600 U Dysport® Placebo Group Drug: 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 Biological: Botulinum toxin type A
800 U intra detrusor injection in two treatment periods (Initial and Retreatment phase) delivered at 30 injection points
Other Names:
  • AbobotulinumtoxinA (Dysport®)
  • Clostridium BTX-A-haemagglutinin complex

Placebo Comparator: 800 U Dysport® Placebo Group Drug: Placebo
AbobotulinumtoxinA Placebo 800 U intra detrusor injection in two treatment periods (Initial and Retreatment phase) delivered at 30 injection points




Primary Outcome Measures :
  1. Change in weekly number of UI episodes [ Time Frame: Baseline, 6 weeks ]
    Measured on a 7-day bladder diary


Secondary Outcome Measures :
  1. Proportion of subjects with no episodes of UI [ Time Frame: Baseline, 6 weeks ]
    Measured on a 7-day bladder diary

  2. Change in incontinence quality of life (I-QoL) total summary score [ Time Frame: Baseline, 6 weeks ]
    Patient-reported outcome questionnaire



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
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): NCT02660359


  Hide Study Locations
Locations
Layout table for location information
Argentina
Instituto Urológico Buenos Aires
Buenos Aires, Argentina, 1060
Centro de Urologia
Buenos Aires, Argentina, C1120AAS
Centro Urológico Profesor Bengió
Córdoba, Argentina, X5000
Hospital Privado - Centro Médico de Córdoba
Córdoba, Argentina, X5016KEH
Instituto Médico Rodriguez Alfici
Godoy Cruz, Argentina, M5501AAP
Australia
Prince of Wales Hospital (POWH)
Sydney, Australia, 2031
Westmead Hospital
Westmead, Australia, 2145
Belgium
Antwerp University hospital
Antwerp, Belgium
Hôpital Erasme
Brussels, Belgium, 1070
Ourthe-Amblève
Esneux, Belgium, 4130
Brazil
Universidade Estadual de Campinas - Cidade Universitária Zeferino Vaz
Campinas, Brazil, 13083-970
Hospital de Clinicas, Federal University of Paraná
Curitiba, Brazil, 80060-900
Hospital São Vicente de Paulo
Passo Fundo, Brazil, 99010-080
Santa Casa de Misericórdia de Porto Alegre - Hospital Santa Clara
Porto Alegre, Brazil, 90020-090
Hospital Moinhos de Vento
Pôrto Alegre, Brazil, 90560-030
Hospital São Lucas da PUCRS
Pôrto Alegre, Brazil, 90610-000
Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto da Universidade de São Paulo
Ribeirao Preto, Brazil, 14048-900
Faculdade de Medicina do ABC
Santo André, Brazil, 09060-650
Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo
Sao Paulo, Brazil, 05422-970
Hospital Alemão Oswaldo Cruz
São Paulo, Brazil, 01323-020
Chile
Clínica Uromed
Santiago, Chile, 7500787
Hospital del Trabajador
Santiago, Chile, 7501241
Clínica Las Condes
Santiago, Chile, 7591046
Colombia
Solano & Terront Servicios Medicos LTDA- Unidad Integral de Endocrinologia
Bogotá, Colombia, 110221
Fundación Valle del Lili
Cali, Colombia, 760032
Centro Medico Imbanaco
Cali, Colombia, 760042
Asociacion IPS Medicos Internistas de Caldas
Manizales, Colombia, 170004
Centro de Investigaciones Clinicas - CIC
Medellin, Colombia, 5001000
France
Hôpital Raymond-Poincaré
Garches, France
Centre Hospitalier Régional Universitaire de Lille (CHRU) - Hôpital Claude Huriez
Lille Cedex, France
Hôpital de la Conception
Marseille CEDEX 5, France
Groupe Hospitalo-Universitaire Pierre Caremau
Nimes Cedex 9, France
Hopital de la Source
Orleans, France
Hôpital Tenon
Paris Cedex 20, France
Hopital Pitie-Salpetriere
Paris, France
Centre Hospitalier Lyon-Sud
Pierre-Bénite, France
CHU de Rennes - Hôpital Pontchaillou
Rennes, France
CHU de ROUEN - Hôpital Charles Nicolle
Rouen Cedex, France
Hôpital Rangueil
Toulouse Cedex 9, France
Germany
Universitätsklinikum Bonn Klinik und Poliklinik für Urologie
Bonn, Germany, 53127
Kliniken Maria Hilf GmbH - Krankenhaus St. Franziskus
Monchengladbach, Germany
Universitätsklinikum Münster
Münster, Germany, 48149
Israel
Rambam Medical Center
Haifa, Israel, 31096
Carmel Medical Center
Haifa, Israel, 34362
Meir Medical Center
Kfar Saba, Israel, 44281
Rabin Medical Center - Davidoff Center
Petah Tikva, Israel, 49100
The Chaim Sheba Medical Center
Ramat Gan, Israel, 52621
Lithuania
Estetines Chirurgijos Centas, UAB
Kaunas, Lithuania, 49476
Vilnius University Hospital Santariskiu Klinikos
Vilnius, Lithuania, 8661
Mexico
Centro Medico Puerta de Hierro - Colima
Colima, Mexico, 28018
Clinstile, S.A. de C.V.
Cuauhtémoc, Mexico, 06700
Hospital Universitario "Dr. José Eleuterio González"
Monterrey, Mexico, 64460
Consultorio Privado
Zapopan, Mexico, 45040
Peru
Clínica San Pablo Surco
Lima, Peru, 15023
Clinica Good Hope
Lima, Peru, Lima18
Clinica Internacional Sede Lima
Lima, Peru, Lima1
Clínica Anglo Americana
Lima, Peru, Lima27
Instituto de Ginecología y Reproducción
Lima, Peru, Lima33
Unidad de Investigación de la Clínica Internacional Sede San Borja
Lima, Peru, Lima41
Russian Federation
Scientific research institute of urology and interventional radiology n. a. N. A. Lopatkin
Moscow, Russian Federation, 105425
Ministry of healthcare of the Russian Federation
Moscow, Russian Federation, 129226
Penza Regional Clinical Hospital n.a. N.N.Burdenko
Penza, Russian Federation, 440026
Rostov State Medical University
Rostov-on-Don, Russian Federation, 344022
St. Petersburg Research Institute of Phthisiopulmonology
Saint Petersburg, Russian Federation, 194064
Pavlov First Saint Petersburg State Medical University
Saint Petersburg, Russian Federation, 197089
City Hospital No. 40
Saint Petersburg, Russian Federation, 197706
Hospital Orkli
Saint Petersburg, Russian Federation
Spain
Complexo Hospitalario Universitario A Coruña
A Coruña, Spain
Fundacio Puigvert
Barcelona, Spain, 08025
Fundació GAEM
Barcelona, Spain
Hospital Universitario Vall d'Hebron
Barcelona, Spain
Hospital Universitario La Paz
Madrid, Spain
Hospital Universitario Virgen del Rocío
Sevilla, Spain
Hospital Universitari i Politècnic La Fe
Valencia, Spain
Ukraine
Municipal Healthcare Institution "Regional Clinical Center of Urology and Nephrology n.a. V.I. Shapoval", Urology Department
Kharkiv, Ukraine, 61037
Kiev City Clinical Hospital No. 3
Kiev, Ukraine, 02125
United Kingdom
NHS Grampian - Aberdeen Royal Infirmary
Aberdeen, United Kingdom, AB25 2ZN
Bedford Hospital
Bedford, United Kingdom, MK42 9DJ
National Hospital for Neurology and Neurosurgery - UCL
London, United Kingdom, WC1N 3BG
Sheffield Teaching Hospitals NHS Foundation Trust - Royal Hallamshire Hospital
Sheffield, United Kingdom, S10 2JF
Royal National Orthopaedic Hospital Trust
Stanmore, United Kingdom, HA7 4LP
The Mid Yorkshire Hospitals NHS Trust - Pinderfields Hospital
Wakefield, United Kingdom, WF1 4DG
Sponsors and Collaborators
Ipsen
Investigators
Layout table for investigator information
Study Director: Ipsen Medical Director Ipsen

Layout table for additonal information
Responsible Party: Ipsen
ClinicalTrials.gov Identifier: NCT02660359     History of Changes
Other Study ID Numbers: D-FR-52120-223
2015-000507-44 ( EudraCT Number )
First Posted: January 21, 2016    Key Record Dates
Last Update Posted: September 16, 2019
Last Verified: September 2019

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
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
Botulinum Toxins
Botulinum Toxins, Type A
abobotulinumtoxinA
Hemagglutinins
Acetylcholine Release Inhibitors
Membrane Transport Modulators