Cannabis for Spasticity in Multiple Sclerosis: A Placebo-Controlled Study
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 41
- 试验地点
- 1
- 主要终点
- Change From Week 0 to Week 3 in the Rate of Torque Increase, Flexion
研究概览
简要总结
The purpose of this study is to learn if the use of inhaled cannabis (marijuana) and oral cannabinoid (dronabinol, Marinol or THC, which is an active ingredient of marijuana) is safe and effective in reducing the symptoms of spasticity and tremor in patients with secondary-progressive or primary progressive multiple sclerosis.
详细描述
The treatment of MS is far from satisfactory. For acute attacks, high dose corticosteroids seem to reduce the duration of attacks and to reduce the likelihood of future attacks. Immunomodulatory agents, available in this disease over the last decade, reduce the frequency of severe attacks by about one third. The remainder of the treatments are symptomatic, aimed at reducing the disability already present.
Recent research into the CB1 and CB2 cannabinoid receptor systems suggest that cannabis may have the potential for affecting both the pathogenic mechanisms and the symptoms of MS. In light of the autoimmune hypothesis of the etiology of MS, THC could directly alter immune function in a manner that might reduce (or increase) the primary pathology of the disease.
Comparisons: Three treatment arms will be compared:
- inhaled cannabis and oral placebo
- inhaled placebo and oral THC
- inhaled placebo and oral placebo
The effects of these agents analyzed at 3 weeks and 7 weeks.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of clinically definite multiple sclerosis as defined by Poser criteria
- •Moderate or severe spasticity
- •Age 21 or older
- •Must live close to the Sacramento, CA area
排除标准
- •Preexisting pulmonary conditions, including poorly controlled asthma, chronic bronchitis, emphysema, bronchiectasis, and other significant pulmonary disorders
- •Preexisting cardiac conditions, including ischemic heart disease, congestive heart failure, and other significant cardiac disorders
- •Inability to abstain from tobacco or marijuana smoking, or use of alcohol or sedative or hypnotic medications during the duration of the study
- •Pre-existing dementia, mania, depression or schizophrenia or other poorly controlled psychiatric illness
- •Past history of abuse of recreational drugs, including marijuana and alcohol in the last 12 months
- •History of or currently meets DSM-IV criteria for dependence on cannabis
- •Use of cannabis, marijuana, or THC in the last four weeks
- •Preexisting dementia, mania, depression, or schizophrenia or other poorly controlled psychiatric illness
- •Exacerbation of MS within 30 days prior to screening visit
- •Current use of cyclophosphamide, mitoxantrone, or cladribine
- •Arthritis, bony and soft tissue disorders interfering with spasticity measures
- •Inability to provide informed consent
- •Recent cannabis use of more than twice per week one month prior to study entry
- •For females of child bearing potential, inability to comply with adequate contraception
研究组 & 干预措施
1) Inhaled Cannabis
Inhaled cannabis is compared to oral placebo.
干预措施: Inhaled Cannabis (Drug)
1) Inhaled Cannabis
Inhaled cannabis is compared to oral placebo.
干预措施: Oral Placebo (Drug)
2) Oral THC
Inhaled placebo is compared to oral THC.
干预措施: Oral THC (Drug)
2) Oral THC
Inhaled placebo is compared to oral THC.
干预措施: Inhaled placebo (Drug)
3) Placebo
Inhaled placebo is compared to oral placebo.
干预措施: Oral Placebo (Drug)
3) Placebo
Inhaled placebo is compared to oral placebo.
干预措施: Inhaled placebo (Drug)
结局指标
主要结局
Change From Week 0 to Week 3 in the Rate of Torque Increase, Flexion
时间窗: Week 0, Week 3
A modified servo-controlled torque motor system (Lido WorkSet II) was designed for this study to analyze the resistance to passive movement of the knee. It determines the amount of torque required to move the knee joint (without voluntary resistance) at high velocities (up to 200 degrees per second) and at slow velocities (as low as 10 degrees per second). The slow displacement torque is a measure of the passive resistance to movement (from the connective tissue and the non-contracting muscle) and the rapid displacement torques are the sum of the passive and active (involuntary) resistance. The active (involuntary) resistance is the result of the stretch reflex and correlates well with the clinical assessment of spasticity. The change was calculated by taking the value at Week 3 and subtracting the value at Week 0. A negative result indicates a decrease in the torque measured and correlates to a decrease in spasticity and a better outcome.
Change From Week 0 to Week 3 in the Rate of Torque Increase, Extension
时间窗: Week 0, Week 3
A modified servo-controlled torque motor system (Lido WorkSet II) was designed for this study to analyze the resistance to passive movement of the knee. It determines the amount of torque required to move the knee joint (without voluntary resistance) at high velocities (up to 200 degrees per second) and at slow velocities (as low as 10 degrees per second). The slow displacement torque is a measure of the passive resistance to movement (from the connective tissue and the non-contracting muscle) and the rapid displacement torques are the sum of the passive and active (involuntary) resistance. The active (involuntary) resistance is the result of the stretch reflex and correlates well with the clinical assessment of spasticity. The change was calculated by taking the value at Week 3 and subtracting the value at Week 0. A negative result indicates a decrease in the torque measured and correlates to a decrease in spasticity and a better outcome.
Change From Week 0 to Week 7 in the Rate of Torque Increase, Flexion
时间窗: Week 0, Week 7
A modified servo-controlled torque motor system (Lido WorkSet II) was designed for this study to analyze the resistance to passive movement of the knee. It determines the amount of torque required to move the knee joint (without voluntary resistance) at high velocities (up to 200 degrees per second) and at slow velocities (as low as 10 degrees per second). The slow displacement torque is a measure of the passive resistance to movement (from the connective tissue and the non-contracting muscle) and the rapid displacement torques are the sum of the passive and active (involuntary) resistance. The active (involuntary) resistance is the result of the stretch reflex and correlates well with the clinical assessment of spasticity. The change was calculated by taking the value at Week 7 and subtracting the value at Week 0. A negative result indicates a decrease in the torque measured and correlates to a decrease in spasticity and a better outcome.
LIDO Machine Score - Rate of Torque Increase, Extension
时间窗: Week 0, Week 7
A modified servo-controlled torque motor system (Lido WorkSet II) was designed for this study to analyze the resistance to passive movement of the knee. It determines the amount of torque required to move the knee joint (without voluntary resistance) at high velocities (up to 200 degrees per second) and at slow velocities (as low as 10 degrees per second). The slow displacement torque is a measure of the passive resistance to movement (from the connective tissue and the non-contracting muscle) and the rapid displacement torques are the sum of the passive and active (involuntary) resistance. The active (involuntary) resistance is the result of the stretch reflex and correlates well with the clinical assessment of spasticity. The change was calculated by taking the value at Week 7 and subtracting the value at Week 0. A negative result indicates a decrease in the torque measured and correlates to a decrease in spasticity and a better outcome.
次要结局
- Change From Week 0 to Week 3 in MS Quality of Life Inventory (MSQLI) - Mental Health Inventory Scale Score(Week 0, Week 3)
- Change From Week 0 to Week 7 in MS Quality of Life Inventory (MSQLI) - Mental Health Inventory Scale Score(Week 0, Week 7)
- Change From Week 0 to Week 3 in MS Quality of Life Inventory (MSQLI) - Modified Social Support Scale Score(Week 0, Week 3)
- Change From Week 0 to Week 3 in Modified Ashworth Score (MAS)(Week 0, Week 3)
- Change From Week 0 to Week 7 in Modified Ashworth Score(Week 0, Week 7)
- Change From Week 0 to Week 3 in Ambulation Index (AI) Score(Week 0, Week 3)
- Change From Week 0 to Week 7 in Ambulation Index (AI) Score(Week 0, Week 7)
- Change From Week 0 to Week 3 in 25 Foot Walk Time(Week 0, Week 3)
- Change From Week 0 to Week 7 in 25 Foot Walk Time(Week 0, Week 7)
- Change From Week 0 to Week 3 in 9 Hole Peg Test (Dominant Hand) Time(Week 0, Week 3)
- Change From Week 0 to Week 7 in 9 Hole Peg Test (Dominant Hand) Time(Week 0, Week 7)
- Change From Week 0 to Week 3 in 9 Hole Peg Test (Non- Dominant Hand) Time(Week 0, Week 3)
- Change From Week 0 to Week 7 in 9 Hole Peg Test (Non- Dominant Hand) Time(Week 0, Week 7)
- Change From Week 0 to Week 3 in Paced Auditory Serial Addition Test (PASAT) Score(Week 0, Week 3)
- Change From Week 0 to Week 7 in Paced Auditory Serial Addition Test (PASAT) Score(Week 0, Week 7)
- Change From Week 0 to Week 3 in Functional System Score - Vision(Week 0, Week 3)
- Change From Week 0 to Week 7 in Functional System Score - Vision(Week 0, Week 7)
- Change From Week 0 to Week 3 in Functional System Score - Brainstem(Week 0, Week 3)
- Change From Week 0 to Week 7 in Functional System Score - Brainstem(Week 0, Week 7)
- Change From Week 0 to Week 3 in Functional System Score - Pyramidal(Week 0, Week 3)
- Change From Week 0 to Week 7 in Functional System Score - Pyramidal(Week 0, Week 7)
- Change From Week 0 to Week 3 in Functional System Score - Cerebellar(Week 0, Week 3)
- Change From Week 0 to Week 7 in Functional System Score - Cerebellar(Week 0, Week 7)
- Change From Week 0 to Week 3 in Functional System Score - Sensory(Week 0, Week 3)
- Change From Week 0 to Week 7 in Functional System Score - Sensory(Week 0, Week 7)
- Change From Week 0 to Week 3 in Functional System Score - Bowel and Bladder(Week 0, Week 3)
- Change From Week 0 to Week 7 in MS Quality of Life Inventory (MSQLI) - SF-36 Mental Component(Week 0, Week 7)
- Change From Week 0 to Week 7 in Functional System Score - Bowel and Bladder(Week 0, Week 7)
- Change From Week 0 to Week3 in MS Quality of Life Inventory (MSQLI) - Modified Fatigue Index Score(Week 0, Week 3)
- Change From Week 0 to Week 3 in Functional System Score - Cerebral(Week 0, Week 3)
- Change From Week 0 to Week 7 in Functional System Score - Cerebral(Week 0, Week 7)
- Change From Week 0 to Week 3 in Expanded Disability Status Score (EDSS)(Week 0, Week 3)
- Change From Week 0 to Week 7 in Expanded Disability Status Score (EDSS)(Week 0, Week 7)
- Change From Week 0 to Week 3 in MS Quality of Life Inventory (MSQLI) - SF-36 Physical Component Score(Week 0, Week 3)
- Change From Week 0 to Week 7 in MS Quality of Life Inventory (MSQLI) - SF-36 Physical Component Score(Week 0, Week 7)
- Change From Week 0 to Week 3 in MS Quality of Life Inventory (MSQLI) - SF-36 Mental Component Score(Week 0, Week 3)
- Change From Week 0 to Week 7 in MS Quality of Life Inventory (MSQLI) - Modified Fatigue Index Score(Week 0, Week 7)
- Change From Week 0 to Week 3 in MS Quality of Life Inventory (MSQLI) - Pain Effects Scale Score(Week 0, Week 3)
- Change From Week 0 to Week 7 in MS Quality of Life Inventory (MSQLI) - Pain Effects Scale Score(Week 0, Week 7)
- Change From Week 0 to Week 3 in MS Quality of Life Inventory (MSQLI) - Sexual Satisfaction Scale Score(Week 0, Week 3)
- Change From Week 0 to Week 7 in MS Quality of Life Inventory (MSQLI) - Sexual Satisfaction Scale Score(Week 0, Week 7)
- Change From Week 0 to Week 3 in MS Quality of Life Inventory (MSQLI) - Bladder Control Scale Score(Week 0, Week 3)
- Change From Week 0 to Week 3 in MS Quality of Life Inventory (MSQLI) - Bowel Control Scale Score(Week 0, Week 3)
- Change From Week 0 to Week 7 in MS Quality of Life Inventory (MSQLI) - Bladder Control Scale Score(Week 0, Week 7)
- Change From Week 0 to Week 3 in MS Quality of Life Inventory (MSQLI) - Impact of Visual Impairment Scale Score(Week 0, Week 3)
- Change From Week 0 to Week 3 in MS Quality of Life Inventory (MSQLI) - Perceived Deficits Scale Score(Week 0, Week 3)
- Change From Week 0 to Week 7 in MS Quality of Life Inventory (MSQLI) - Modified Social Support Scale Score(Week 0, Week 7)
- Change From Week 0 to Week 7 in MS Quality of Life Inventory (MSQLI) - Bowel Control Scale Score(Week 0, Week 7)
- Change From Week 0 to Week 7 in MS Quality of Life Inventory (MSQLI) - Impact of Visual Impairment Scale Score(Week 0, Week 7)
- Change From Week 0 to Week 7 in MS Quality of Life Inventory (MSQLI) - Perceived Deficits Scale Score(Week 0, Week 7)