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Trial record 8 of 645 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 : Completed
First Posted : January 21, 2016
Last Update Posted : July 26, 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

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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



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Key Inclusion Criteria:

  • Urinary Incontinence for at least 3 months prior to Screening as a result of Neurogenic Detrusor Overactivity due to Spinal Cord Injury or Multiple Sclerosis.
  • Subjects with Spinal Cord Injury must have a stable neurological injury at T1 level or below which occurred at least 6 months prior to Screening.
  • Subjects with Multiple Sclerosis must be clinically stable in the investigator's opinion, with no exacerbation (relapse) of MS for at least 3 months prior to Screening.
  • Subjects must have had an inadequate response after at least 4 weeks of oral medications used in the treatment of NDO (e.g. anticholinergics, beta-3 agonists) and/or have intolerable side-effects.
  • Routinely performing Clean Intermittent Catheterization (CIC) to ensure adequate bladder emptying.
  • An average of at least two episodes per day of Urinary Incontinence recorded on the screening bladder diary.

Key Exclusion Criteria:

  • Any current condition (other than NDO) that may impact on bladder function.
  • Previous or current, tumour or malignancy affecting the spinal column or spinal cord, or any other unstable cause of SCI.
  • Any condition that will prevent cystoscopic treatment administration or CIC usage, e.g. urethral strictures.
  • Current indwelling bladder catheter, or removal of indwelling bladder catheter less than 4 weeks prior to Screening.
  • BTX-A treatment within 9 months prior to Screening for any urological condition (e.g. detrusor or urethral sphincter treatments).
  • Any neuromodulation/electrostimulation usage for urinary symptoms/incontinence within 4 weeks prior to Screening. Any implanted neuromodulation device must be switched off at least 4 weeks prior to Screening.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02660359


  Show 82 Study Locations
Sponsors and Collaborators
Ipsen
Investigators
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Study Director: Ipsen Medical Director Ipsen

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Responsible Party: Ipsen
ClinicalTrials.gov Identifier: NCT02660359     History of Changes
Other Study ID Numbers: D-FR-52120-223
First Posted: January 21, 2016    Key Record Dates
Last Update Posted: July 26, 2019
Last Verified: July 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Multiple Sclerosis
Spinal Cord Injuries
Urinary Incontinence
Enuresis
Urinary Bladder, Overactive
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Spinal Cord Diseases
Central Nervous System Diseases
Trauma, Nervous System
Wounds and Injuries
Urination Disorders
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Signs and Symptoms
Behavioral Symptoms
Elimination Disorders
Mental Disorders
Urinary Bladder Diseases
Botulinum Toxins
Botulinum Toxins, Type A
abobotulinumtoxinA
Hemagglutinins
Acetylcholine Release Inhibitors
Membrane Transport Modulators