A Double Blind, Randomised, Placebo Controlled, Parallel Group Study of Cannabis Based Medicine (CBM) Extract, in Patients Suffering Detrusor Overactivity Associated With Multiple Sclerosis.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 135
- 试验地点
- 1
- 主要终点
- Change From Baseline in the Mean Daily Number of Incontinence Episodes at the End of Treatment
研究概览
简要总结
The purpose of this study is to evaluate the efficacy of Sativex® compared with placebo in reducing the daily number of episodes on incontinence.
详细描述
This is a ten week, multicentre, double blind, randomised, placebo controlled parallel group study to evaluate the efficacy of Sativex® on urge incontinence associated with neurogenic unstable bladder. Multiple sclerosis patients with incontinence symptoms are screened to determine eligibility and complete a two-week baseline period. They then return for a further eligibility check, randomisation and initial dosing. Subjects titrate and self-medicate with study medication between study visits at weeks two and five. They will also complete efficacy assessments in their diary-books and at visits.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Willing and able to give informed consent.
- •Male or female, aged 18 years or over.
- •Diagnosed with MS and with detrusor overactivity not wholly relieved by current therapy.
- •At least three incontinence episodes within five consecutive days during the baseline period
- •Stable dose of anticholinergic medication for at least 14 days leading to study entry.
- •Agreement, if female and of child bearing potential or if male with a partner of child bearing potential, to ensure that effective contraception is used during the study and for three months thereafter.
- •Has not used cannabinoids (including cannabis, Marinol® or nabilone) for at least seven days before Visit 1 and willing to abstain from any use of cannabinoids during the study.
- •Agreement for the UK Home Office, their general practitioner, and their consultant if appropriate, to be notified of their participation in the study.
排除标准
- •A symptomatic UTI or any cause of detrusor overactivity other than neurogenic causes due to MS.
- •Using ISC.
- •A history of schizophrenia, other psychotic illness, severe personality disorder or other significant psychiatric disorder other than depression associated with their underlying condition.
- •A history of alcohol or substance abuse.
- •A severe cardiovascular disorder, such as ischaemic heart disease, arrhythmias (other than well controlled atrial fibrillation), poorly controlled hypertension or severe heart failure.
- •A history of epilepsy.
- •If female, are pregnant of lactating, or are planning a pregnancy to occur during the course of the study.
- •Significant renal or hepatic impairment.
- •Elective surgery or other procedures requiring general anesthesia scheduled to occur during the study.
- •Terminal illness or any other significant disease or disorder which, in the opinion of the investigator, may either put the subject at risk because of participation in the study or influence the result of the study, or the subjects ability to participate in the study.
- •Regular levodopa (Sinement®, Sinement Plus®, Levodopa, L-dopa, Madopar®, Benserazide) within the seven days leading up to study entry.
- •Receiving and unwilling to stop fentanyl for the duration of the study.
- •Known or suspected hypersensitivity to cannabinoids or any of the excipients of the study medications.
- •Intention to travel internationally or to donate blood during the study.
- •Participation in another research study in the 12 weeks leading up to study entry.
- •Previous randomization in to this study
研究组 & 干预措施
Sativex
Each 100 ul actuation contains 27 mg delta-9-tetrahydrocannabinol (THC) and 25 mg cannabidiol (CBD). A maximum of 48 actuations (130 mg of THC and 120 mg of CBD) was permitted in any 24 hour period.
干预措施: Sativex® (Drug)
Placebo
Each 100 ul actuation contains the colorants plus excipients. A maximum of 48 actuations was permitted in any 24 hour period.
干预措施: Placebo (Drug)
结局指标
主要结局
Change From Baseline in the Mean Daily Number of Incontinence Episodes at the End of Treatment
时间窗: 0 - 10 weeks
To assess the effect of Sativex in neurogenic overactive bladder, the incontinence episode frequency was selected as the primary endpoint. Baseline was the average of all available data recorded during the 14 days immediately prior to the randomisation visit. End of Treatment was the last average available from Week 3, Week 5, and Weeks 7-8. A negative value indicates an improvement in score from baseline.
次要结局
- Change From Baseline in the Mean Daily Number of Incontinence Pads Used at the End of Treatment(0 - 10 weeks)
- Change From Baseline in Mean Overall Bladder Condition 0-10 Numerical Rating Scale Score at the End of Treatment(0 - 10 weeks)
- Patient's Global Impression of Change(0 - 10 weeks)
- Change From Baseline in the Mean Number of Daily Voids at the End of Treatment(0 - 10 weeks)
- Change From Baseline in the Mean Daily Episodes of Nocturia at the End of Treatment(0 - 10 weeks)
- Change From Baseline in the Mean Daily Episodes of Urgency at the End of Treatment(Daily diary entries throughout 10 week study period)
- Change From Baseline in Mean Total Incontinence Quality of Life (I-QOL) Questionnaire Score at the End of Treatment (Completion or Withdrawal)(0 - 10 weeks)