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Dysport® Treatment of Urinary Incontinence in Adults Subjects With Neurogenic Detrusor Overactivity (NDO) Due to Spinal Cord Injury or Multiple Sclerosis - Study 1 (CONTENT1)

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ClinicalTrials.gov Identifier: NCT02660138
Recruitment Status : Active, not recruiting
First Posted : January 21, 2016
Last Update Posted : November 30, 2018
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® (AbobotulinumtoxinA) 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 Drug: AbobotulinumtoxinA Drug: AbobotulinumtoxinA Placebo Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 217 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
Study Start Date : March 2016
Estimated Primary Completion Date : November 2018
Estimated Study Completion Date : March 31, 2019


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

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

Placebo Comparator: 800 U Dysport® Placebo Group Drug: AbobotulinumtoxinA 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. Change in maximum cystometric capacity (MCC) [ Time Frame: Baseline, 6 weeks ]
    MCC is maximum amount of fluid the bladder can hold.

  2. Change in maximum detrusor pressure (MDP) during storage [ Time Frame: Baseline, 6 weeks ]
    MDP is maximum pressure that occurs in the bladder when the bladder is storing fluid.

  3. Change in volume at first involuntary detrusor contraction (Vol@1stIDC) [ Time Frame: Baseline, 6 weeks ]
    Volume at first involuntary detrusor contraction is amount of fluid in the bladder when the bladder first starts having abnormal contractions

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

  5. Proportion of subjects with no involuntary detrusor contraction (IDCs) during storage [ Time Frame: Baseline, 6 weeks ]
    Measured by urodynamic filling cystometry

  6. 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): NCT02660138


  Show 81 Study Locations
Sponsors and Collaborators
Ipsen
Investigators
Study Director: Ipsen Medical Director Ipsen

Responsible Party: Ipsen
ClinicalTrials.gov Identifier: NCT02660138     History of Changes
Other Study ID Numbers: D-FR-52120-222
2015-003471-30 ( EudraCT Number )
First Posted: January 21, 2016    Key Record Dates
Last Update Posted: November 30, 2018
Last Verified: November 2018

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant 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
abobotulinumtoxinA
Botulinum Toxins, Type A
onabotulinumtoxinA
Hemagglutinins
Acetylcholine Release Inhibitors
Membrane Transport Modulators