A Randomised, Double Blind, Placebo Controlled, Parallel Group Comparative Study of the Efficacy, Safety and Tolerability of Sublingual Cannabis Based Medicine Extracts and Placebo in Patients With Intractable Neuropathic Pain Associated With Spinal Cord Injury
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 116
- 试验地点
- 1
- 主要终点
- Change From Baseline in Mean Central Neuropathic Pain 11-Point Numerical Rating Scale Scores at the End of Treatment (up to 51 Days).
研究概览
简要总结
A study to investigate the effects of sublingual cannabis based medicine extracts on neuropathic pain associated with spinal cord injury.
详细描述
This was a multi-centre, double-blind, randomised, placebo-controlled, parallel-group study to evaluate the efficacy and tolerability of GW-1000-02 in central neuropathic pain associated with spinal cord injury. Patients were screened to determine eligibility and completed a seven to 21 day baseline period. Patients then returned to the centre for assessment, randomisation and initial dosing. Visits occurred at the end of treatment week one and at the end of the study (treatment week three) or upon withdrawal. Throughout the study, patients were permitted to take paracetamol as escape analgesic to relieve breakthrough pain. Patients in this study could elect to be screened for an open label extension study of GW-1000-02.
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
- •Gave informed consent for participation in the study.
- •Male or Female, aged 18 years or above.
- •Diagnosis of non-acute spinal cord injury, with central neuropathic pain not wholly relieved by current therapy.
- •Central neuropathic pain with a mean severity Numerical Rating Scale score at least four during last seven days of the baseline period.
- •Relatively stable neurology during the preceding six months.
- •Stable medication regimen during the preceding four weeks.
- •Agreement, if female and of child bearing potential or if male with a partner of child bearing potential, to ensure that effective contraception was used during the study and for three months thereafter.
- •Had not used cannabinoids for at least the preceding seven days and willing to abstain from any use of cannabinoids during the study.
- •Clinically acceptable laboratory results at Visit
- •Ability (in the investigator's opinion) and willingness to comply with all study requirements.
- •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
- •History of schizophrenia, other psychotic illness, severe personality disorder or other significant psychiatric disorder other than depression associated with their underlying condition.
- •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 autonomic dysreflexia.
- •History of epilepsy.
- •If female, were pregnant or lactating, or were planning a pregnancy to occur during the course of the study.
- •Significant renal or hepatic impairment.
- •Elective surgery or other procedures requiring general anaesthesia scheduled to occur during the study.
- •Terminal illness or were considered inappropriate for placebo medication.
- •Any other significant disease or disorder which, in the opinion of the investigator, may have either put the subject at risk because of participation in the study, or may influenced the result of the study, or the subject's ability to participate in the study.
- •Regular levodopa therapy within the seven days leading to study entry.
- •If male, were receiving and were unwilling to stop sildenafil for the duration of the study.
- •Known or suspected hypersensitivity to cannabinoids or any of the excipients of the study medications.
- •Known or suspected adverse reaction to cannabinoids.
- •Intention to travel internationally during the study.
- •Intention to donate blood during the study.
- •Participation in another research study in the 12 weeks leading to study entry.
- •Previous randomisation into this study.
研究组 & 干预措施
Placebo
Placebo control.
干预措施: Placebo (Drug)
GW-1000-02
Active treatment.
干预措施: GW-1000-02 (Drug)
结局指标
主要结局
Change From Baseline in Mean Central Neuropathic Pain 11-Point Numerical Rating Scale Scores at the End of Treatment (up to 51 Days).
时间窗: Up to 51 days
The Central Neuropathic Pain Numerical Rating Scale score was recorded three times daily, in the morning (on waking), at lunchtime and in the evening using the scale, 0 = 'No Pain' and 10 = 'Worst Possible Pain'. Patients were instructed to relate 'No Pain' to the time before the start of their spinal cord injury. End of Treatment was defined as the mean of the last seven days in the study or the mean of the last three days if the subject withdrew. A negative value indicates an improvement in pain score from baseline.
次要结局
- Change From Baseline in the Mean Percentage of Days on Which Escape Medication Was Used at the End of Treatment(Up to 51 days)
- Change From Baseline in Mean Spasticity Severity Numerical Rating Scale Scores the End of Treatment.(0 - 51 days)
- Change From Baseline in the Percentage of Days on Which Spasticity Was Experienced at the End of Treatment(Up to 51 days)
- Change From Baseline in Modified Ashworth Scale Score at the End of Treatment(Up to 51 days)
- Change From Baseline in the Mean Short Orientation Memory Function Concentration Test Score at the End of Treatment(Up to 51 days)
- Change From Baseline in Mean Spitzer Quality of Life Index Score at the End of Treatment(Up to 51 days)
- Change From Baseline in the Mean Caregiver Strain Index Score at the End of Treatment(Up to 51 days)
- Change From Baseline in Mean Spasm Severity Numerical Rating Scale Score at the End of Treatment(Up to 51 days)
- Change From Baseline in the Mean Brief Pain Inventory Score at the End of Treatment(0 - 51 days)
- Change From Baseline in the Percentage of Days on Which Spasm Was Experienced at the End of Treatment(Up to 51 days)
- Number of Subjects Who Reported an Improvement in Their Overall Condition in the Patient Global Impression of Change at the End of Treatment(Up to 51 days)
- Change From Baseline in the Mean Sleep Disturbance Numerical Rating Scale Score at the End of Treatment(0 - 51 days)
- Incidence of Adverse Events as a Measure of Patient Safety.(Up to 61 days)