NCT02660359终止3 期
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
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- Ipsen
- 入组人数
- 258
- 试验地点
- 82
- 主要终点
- Mean Change From Baseline in Weekly Number of UI Episodes at Week 6 of DBPC Cycle
研究概览
简要总结
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
600 U Dysport® Group
Experimental
干预措施: Botulinum toxin type A (Biological)
600 U Dysport® Placebo Group
Placebo Comparator
干预措施: Placebo (Drug)
800 U Dysport® Group
Experimental
干预措施: Botulinum toxin type A (Biological)
800 U Dysport® Placebo Group
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Mean Change From Baseline in Weekly Number of UI Episodes at Week 6 of DBPC Cycle
时间窗: Baseline and 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.
次要结局
- Mean Change From Baseline in Maximum Detrusor Pressure (MDP) During Storage at Week 6 of DBPC Cycle(Baseline and Week 6 of DBPC Cycle)
- Percentage of Subjects With No Episodes of UI at Week 6 of DBPC Cycle(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(Baseline and Week 6 of DBPC Cycle)
- Mean Change From Baseline in Volume Per Void 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)
- Median Time Between Treatments(Day of first treatment (baseline) to day of retreatment, up to 2 years)
- Mean Change From Baseline in Maximum Cystometric Capacity (MCC) at Week 6 of DBPC Cycle(Baseline and Week 6 of DBPC Cycle)
- Percentage of Subjects With No Involuntary Detrusor Contraction (IDCs) During Storage at Week 6 of DBPC Cycle(Baseline and Week 6 of DBPC Cycle)
研究者
研究点 (82)
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