A Multi Centre Randomised, Double Blind, Placebo Controlled, Parallel Group Comparison of the Effects of Cannabis Based Medicine Standardised Extracts Over 4 Weeks, in Patients With Chronic Refractory Pain Due to Multiple Sclerosis or Other Defects of Neurological Function.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Change From Baseline in Mean Pain Box Scale-11 Score at 3 Weeks.
研究概览
简要总结
To investigate the ability of a cannabis based medicine extract to relieve chronic refractory pain of neurological origin.
详细描述
Patients with Multiple Sclerosis or other defect of neurological function with a qualifying symptom of chronic refractory pain, entered a seven day baseline period, followed by a 21 day randomised, double blind, parallel group comparison of GW-1000-02 with placebo, self-titrated to symptom resolution or maximum tolerated dose. The ability of the cannabis based medicine extract to relieve chronic refractory pain was assessed by the change from baseline in pain score using Box Scale-11 (BS-11) scores recorded in the patients' daily diary.
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
- 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
- •Patient, or legal representative, willing and able to give informed consent for participation in the study.
- •Male or Female, aged 18 years or above.
- •Diagnosed with chronic refractory pain due to Multiple Sclerosis or other defects of neurological function.
- •Diagnosed with pain, not wholly alleviated with current analgesic therapy at Visit 1 and an average score of over 4 on a Box Scale-11 scale on the four consecutive days leading up to Visit 2, where: zero = "no pain" and 10 = "worst possible pain".
- •Stable dose of pain relieving medication for at least two weeks prior to study entry.
- •Willing to ensure that they or their partner use effective contraception during the study and for three months thereafter (applicable to female patients of child bearing potential and male patients whose partners were of child bearing potential).
- •No cannabinoid use (cannabis, Marinol or Nabilone) for at least seven days before Visit 1 and be willing to abstain from any use of cannabis during the study.
- •Able (in the investigator's opinion) and willing to comply with all study requirements.
- •Willing for his or her name to be notified to the Home Office for participation in this study.
- •Willing to allow his or her general practitioner 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 (other than well controlled atrial fibrillation), poorly controlled hypertension or severe heart failure.
- •History of epilepsy.
- •Female patients who were 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.
- •Terminally ill or inappropriate for placebo medication.
- •Any other significant disease or disorder which, in the opinion of the investigator, may have put the patient at risk because of participation in the study, or may have influenced the result of the study, or the patient's ability to participate in the study.
- •Regular levodopa (Sinemet®, Sinemet Plus®, Levodopa, L-dopa, Madopar®, Benserazide) therapy within seven days of study entry.
- •Known or suspected hypersensitivity to cannabinoids or any of the excipients of the study medications.
- •Known or suspected of having adverse reaction to cannabinoids.
- •Travel outside the UK planned during the study.
- •Donation of blood during the study.
- •Patients who had participated in another research study in the 12 weeks leading up to study entry.
- •Patients who had been previously randomised into this study.
- •Male patients who were receiving Sildenafil (Viagra®) at the time of study entry and were unwilling to stop medication for the duration of the study.
研究组 & 干预措施
GW-1000-02
Each 100 μl actuation contains 2.5 mg delta-9-tetrahydrocannabinol (THC) and 2.5 mg cannabidiol (CBD). The maximum permitted dose was 48 actuations in any 24 hour period (120 mg THC/120 mg CBD).
干预措施: GW-1000-02 (Drug)
Placebo
Each 100 μl actuation contains the excipients only. The maximum permitted dose was 48 actuations in any 24 hour period
干预措施: Placebo (Drug)
结局指标
主要结局
Change From Baseline in Mean Pain Box Scale-11 Score at 3 Weeks.
时间窗: 0 - 3 weeks
Each day, in the morning (on waking), at lunchtime and in the evening (just before going to bed), patients recorded in their patient diary their level of pain using a Box Scale-11 pain score ranging from zero "no pain" to 10 "worst possible pain". Week 3 analysis was defined as the mean of the last seven days in the study. The last day was taken as the last day with complete diary card pain data that occurred on or before the last day the patient took study medication. A negative value from baseline indicates and improvement.
次要结局
- Use of Analgesic Escape Medication - Multiple Sclerosis Subset.(0 - 3 weeks)
- Change From Baseline in Mean Pain Box Scale-11 Scores (Multiple Sclerosis Subset) at 3 Weeks.(0 - 3 weeks)
- Use of Analgesic Escape Medication.(0 - 3 weeks)
- Change From Baseline in Mean Total Pain Disability Index Score at 3 Weeks.(0 - 3 weeks)
- Patient Global Impression of Change at the End of 3 Weeks of Treatment.(0 - 3 weeks)
- Change From Baseline in Mean Sleep Disturbance Score at 3 Weeks.(0 - 3 weeks)
- Change From Baseline in Mean Total Brief Pain Inventory (Short Form) Score at 3 Weeks.(0 - 3 weeks)
- Change From Baseline in Mean Brief Pain Inventory (Short Form) Scores (Multiple Sclerosis Subset) at 3 Weeks.(0 - 3 weeks)
- Change From Baseline in Mean Spitzer Quality of Life Index Scores at 3 Weeks.(0 - 3 weeks)
- Change From Baseline in Mean Pain Disability Index Scores at 3 Weeks.(0 - 3 weeks)
- Change From Baseline in Mean Sleep Disturbance Scores (Multiple Sclerosis Subset) at 3 Weeks.(0 - 3 weeks)
- Change From Baseline in Mean Spitzer Quality of Life Index Scores (Multiple Sclerosis Subset) at 3 Weeks.(0 - 3 weeks)
- Patient Global Impression of Change - Multiple Sclerosis Subset.(0 - 3 weeks)
- Incidence of Adverse Events as a Measure of Patient Safety.(0 - 65 days)