A Randomized Double-Blinded Crossover Trial Assessing the Effect of Cannabinoids on Spasticity and Neuropathic Pain in Spinal Cord Injured Persons
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Ashworth Scale
研究概览
简要总结
This study is being conducted to study the effect of nabilone (a synthetic cannabinoid)on spasticity in spinal cord injured persons.The study will be a phase 2, randomized, placebo-controlled crossover study. Each eligible subject will participate for 26 weeks.Subjects will be randomized to receive either nabilone or placebo during phase 1 of the study. Study drug will be titrated up from 0.5mg daily to a maximum of 3.0 mg daily over the first 11-week phase. Following a 4-week washout period, subjects will be crossed-over to the opposite arm for another 11 week treatment period (phase 2).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Spinal Cord Injury
- •12 months post -injury
- •C2-T12, ASIA A-D, stable level of injury
- •moderate to severe spasticity or moderate to severe neuropathic pain
- •no cognitive impairment
- •spasticity medications unchanged for at least 30 days or inadequate pain control at a stabilized dose of either gabapentin or pregabalin for at least 30 days
- •no botulinum toxin injections x 6 months
排除标准
- •significant cardiovascular disease
- •major illness in another body area
- •history of psychological disorders or predisposition to psychosis
- •sensitivity to cannabinoids
- •severe liver disfunction
- •history of drug dependancy
- •fixed tendon contractures
- •used cannabis in the past 30 days
- •unwilling to refrain from smoking cannabis during the study
- •pregnant or nursing mother
研究组 & 干预措施
nabilone
nabilone 0.5 mg tablets dose-titrated over an 11-week period to a maximum of 3mg po daily. Subjects are allowed to drop back to the previous dose following a dose increase once if required
干预措施: nabilone 0.5 mg (Drug)
placebo
look-alike 0.5 mg placebo tablets titrated to a maximum daily dose of 3.0 mg daily over an 11-week phase. Subjects are allowed to drop back to the previous dose following a dose increase once during the 11-week phase if required
干预措施: placebo (Drug)
结局指标
主要结局
Ashworth Scale
时间窗: 26 weeks
A scale that grades resistance to rapid passive movement across a relaxed joint on an ordinal scale of 0 to 4.
VAS (visual analog scale)pain intensity scale
时间窗: 26 weeks
Primary outcome measure for pain will be a change in the VAS pain intensity scale. Using a visual intensity scale, patients are asked to record their daily pain score over the previous 24 hours.
次要结局
- Subject's Global Impression of Change(26 weeks)
- The Short Form McGill Pain Questionnaire (SF-MPQ)(26 weeks)
- VAS Pain Impact Scale(26 weeks)
- Neuropathic Pain Questionnaire(26 weeks)
- Sum of the Ashworth Scale in the eight muscle groups of each side of the body.(26 weeks)
- Pittsburgh Sleep Quality Index(26 weeks)
- Penn Spasm Frequency Scale(26 weeks)
- Visual Analog Scale(26 weeks)
- Clinician's Global Impression of Change(26 weeks)
研究者
Dr. Karen Ethans
Principal Investigator MD
University of Manitoba