MSFrontier

CONTENT1

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
Stopped earlyPhase 3MS (type not specified)NCT026601382015-003471-30

What it found

Stopped early

The trial ended early for another reason (see below).

Reason given: Low recruitment of patients

What was tested

Treatment tested

  • Botulinum toxin type a

    Synaptosomal nerve-associated protein 25 (SNAP-25) hydrolytic enzyme

  • Onabotulinumtoxina

    Synaptosomal nerve-associated protein 25 (SNAP-25) inhibitor

Placebo or sham

  • Placebo

Results by group

Mean Change From Baseline in Weekly Number of UI Episodes at Week 6 of DBPC Cycle

Baseline and Week 6 of DBPC Cycle

GroupValueIntervalNumber analysed
Placebo-12.7 Weekly UI episodes2.01 (Standard Error)64
Dysport® 600 U-23.5 Weekly UI episodes2.04 (Standard Error)62
Dysport® 800 U-24.9 Weekly UI episodes1.97 (Standard Error)67

Placebo

-12.7

Dysport® 600 U

-23.5

Dysport® 800 U

-24.9

p = 0.0001; LS Mean Difference -10.83 (95% CI -16.36–-5.31)

Values as posted on ClinicalTrials.gov. Outcomes measured differently across trials are not directly comparable.

Safety

GroupParticipants at riskSerious adverse eventsDeaths
Placebo768 (10.5%)0
Dysport® 600 U739 (12.3%)0
Dysport® 800 U776 (7.8%)0

As posted on ClinicalTrials.gov. Serious adverse events include any serious health event during the trial, whether or not the treatment caused it.

What it measured

Main measures

  • Mean Change From Baseline in Weekly Number of UI Episodes at Week 6 of DBPC Cycle

    Baseline and Week 6 of DBPC Cycle

    Bladder, bowel and sexual function

  • Mean change from study Baseline (assessed at Screening) to Week 6 after the first IMP administration in the weekly number of UI episodes

Other measures (10)

  • Mean Change From Baseline in Maximum Cystometric Capacity (MCC) at Week 6 of DBPC Cycle

    Baseline and Week 6 of DBPC Cycle

  • Mean Change From Baseline in Maximum Detrusor Pressure (MDP) at Week 6 of DBPC Cycle

    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

    Baseline and Week 6 of DBPC Cycle

  • Number of Subjects With No Episodes of UI at Week 6 of DBPC Cycle

    Baseline and Week 6 of DBPC Cycle

    Bladder, bowel and sexual function

  • Number of Subjects With No IDCs During Storage at Week 6 of DBPC Cycle

    Baseline and Week 6 of DBPC Cycle

  • Mean Change From Baseline in Incontinence Quality of Life (I-QoL) Questionnaire Total Summary Score at Week 6 of DBPC Cycle

    Baseline and Week 6 of DBPC Cycle

    Bladder, bowel and sexual functionQuality of life (reported by participants)

  • Number of Subjects With a UI Response at Improvement Levels ≥30%, ≥50%, and ≥75% at Week 6 of the DBPC Cycle

    Baseline and Week 6 of DBPC Cycle

    Bladder, bowel and sexual function

  • Mean Change From Baseline in Volume Per Void at Week 6 of DBPC Cycle

    Baseline and Week 6 of DBPC Cycle

    Bladder, bowel and sexual function

  • Median Time Between Treatments

    Day of first treatment (baseline) and day of retreatment, up to 2 years

  • Bladder diary measures:

    Bladder, bowel and sexual function

Who could take part

MS (type not specified) · 18 to 80

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.

As registered. Criteria can change, so ask the trial team or your neurologist.

About this trial

In the sponsor's words

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).

Papers

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Related trials

History

    1. Started

      Mar 2016

    2. Main results due

      Nov 2018

    3. Finished

      Feb 2019

    4. Results posted

      Jun 2021

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