A Double Blind, Randomised, Parallel Group Study to Assess the Efficacy, Safety and Tolerability of Cannabis Based Medicine 1:1 THC:CBD Compared With Placebo for the Treatment of Spasticity in Patients With Multiple Sclerosis.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 189
- 试验地点
- 1
- 主要终点
- Assessment of Change From Baseline in the Mean Spasticity 0-10 Numerical Rating Scale Score.
研究概览
简要总结
The purpose of this study is to evaluate the efficacy, safety and tolerability of Sativex® in subjects diagnosed with MS and spasticity.
详细描述
This was an eight week (two weeks baseline, six weeks treatment), multicentre, double blind, randomised, placebo controlled parallel group study to evaluate the efficacy, safety and tolerability of Sativex® in subjects diagnosed with MS and spasticity. Subjects were screened to determine eligibility and completed a two week baseline period. Subjects then returned to the site for assessment, randomisation and dose introduction. Visits occurred at the end of treatment week two and at the end of the study (treatment week six) or withdrawal.
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 above.
- •Stable disease for at least three months prior to study entry, in the opinion of the investigator.
- •Diagnosed with MS whose spasticity was not wholly relieved with the therapy at the time of study entry.
- •Significant spasticity in at least two muscle groups defined as a score of two or more on the Ashworth Scale for each muscle group.
- •Stable dose of current anti-spasticity medication for at least 30 days prior to study entry.
- •Willing to maintain a stable dose of anti-spasticity medication and level of physiotherapy for the duration of the study.
- •Clinically acceptable laboratory results at Visit
- •Willing, if female and of child bearing potential or male subjects with a partner of child bearing potential, to ensure that effective contraception was used during the study and for three months thereafter.
- •No cannabinoid use (cannabis, Marinol® or Nabilone) for at least seven days before Visit 1 and were willing to abstain from any use of cannabis during the study.
- •Able (in the investigators opinion) and willing to comply with all study requirements.
- •Willing for the Home Office to be notified of his or her participation in the study (applicable to the UK centres only).
- •Willing to allow his or her GP and consultant, if appropriate, to be notified of participation in the study.
排除标准
- •History of schizophrenia, other psychotic illness, severe personality disorder or other significant psychiatric disorder other than depression associated with their underlying condition.
- •Known history of alcohol or substance abuse.
- •Severe cardiovascular disorder, such as ischaemic heart disease, arrhythmias, poorly controlled hypertension or severe heart failure.
- •History of epilepsy.
- •Female subject who was pregnant, lactating or planning pregnancy during the course of the study.
- •Significant renal or hepatic impairment.
- •Scheduled elective surgery or other procedures requiring general anaesthesia during the study.
- •Subject who was terminally ill or was inappropriate for placebo medication.
- •Any other significant disease or disorder which, in the opinion of the investigator, either put the subject at risk because of participation in the study, or influenced the result of the study, or the subject's ability to participate in the study.
- •Regular levodopa (Sinemet®, Sinemet Plus®, Levodopa, L-dopa, Madopar®, Benserazide) therapy within seven days of study entry.
- •Male subject receiving sildenafil (Viagra®) and unwilling to stop medication for the duration of the study.
- •Subjects who were taking fentanyl (Durogesic®, Actiq®)
- •Subjects who were taking antiarrhythmic medications.
- •Known or suspected hypersensitivity to cannabinoids or any of the excipients of the study medications.
- •Known or suspected adverse reaction to cannabinoids.
- •Planned travel outside the UK during the study (applicable to the UK centres only).
- •Donation of blood during the study.
- •Subjects who had participated in another research study in the 12 weeks prior to study entry.
- •Subjects previously randomised into this study.
研究组 & 干预措施
Placebo
干预措施: Placebo (Drug)
Sativex
干预措施: Sativex® (Drug)
结局指标
主要结局
Assessment of Change From Baseline in the Mean Spasticity 0-10 Numerical Rating Scale Score.
时间窗: 0-52 days
The spasticity Numerical Rating Scale was completed at the same time each day, i.e. bedtime in the evening. The patient was asked "on a scale of '0 to 10', please indicate the number that best describes your average spasticity in the last 24 hours" where 0 = no spasticity and 10 = worst ever spasticity. For the analysis, end of treatment was defined as the mean of the last seven days in the study or the last three days if the subject withdrew due to worsening spasticity or lack of efficacy. A negative value indicates an improvement in spasticity score from baseline.
次要结局
- Change From Baseline in Mean Ashworth Scale Score at the End of Treatment(Days 0 - 52)
- Patient's Global Impression of Change in Condition at the End of Treatment(Day 52)
- Change From Baseline in Mean Spasm Frequency Score at the End of Treatment(Days 0 - 52)
- Change From Baseline in Mean Motricity Index Score for the Arms(Day 7 and 52)
- Incidence of Adverse Events as a Measure of Subject Safety(Day 0-52)
- Change From Baseline in Mean Motricity Index Score for the Legs(Day 7 and Day 52)