Randomised, Double-blind, Placebo-controlled Phase III Trial to Determine the Efficacy and Safety of a Standardised Oral Extract of Cannabis Sativa for the Symptomatic Relief of Muscle Stiffness and Pain in Multiple Sclerosis.
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- 入组人数
- 279
- 试验地点
- 1
- 主要终点
- Change in muscle stiffness: 11-point numerical Likert scale
研究概览
简要总结
Study Objectives: To determine the efficacy and safety of a standardised extract of Cannabis sativa given orally 2 times daily as compared to placebo for the relief of muscle stiffness and pain in multiple sclerosis for a period of 12 weeks.
Study Patients: 400 patients with multiple sclerosis (age 18-64, stable disease during previous 6 months, ambulatory or not, antispasticity medication and physiotherapy stabilised ≥ 30 days) with experiencing muscle stiffness ≥ 4 on a 11-point numerical Likert scale at baseline.
Study treatment:
Group 1: Cannabis extract (delta-9-THC 2.5mg, CBD 1.25 mg per capsule), flexible dosing between 5 mg and 25 mg THC/d, administered twice daily, additionally to previous antispasticity and analgesic medication.
Group 2: Matched placebo, twice daily, additionally to previous antispasticity and analgesic medication.
Treatment Schedule: Start dose 5 mg THC/d, individual dose titration with increase of 5 mg THC every 3 days, maximal total daily dose 25 mg THC, administered as 2 equal doses based on tolerability. Treatment duration: 12 weeks.
Study sites: 20 neurological clinics in the United Kingdom.
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 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signed informed consent.
- •Diagnosis of MS according to McDonald criteria.
- •Current muscle stiffness ≥ 4 on a 11-point categorical rating scale.
- •On-going troublesome muscle stiffness for at least 3 months.
- •Stable disease for the previous 6 months.
- •Antispasticity medication and physiotherapy stabilised for the last 30 days.
- •Patients may be ambulatory or not.
- •Age 18-64.
排除标准
- •Immunosuppressants which may affect spasticity (including corticosteroids and interferon but ex-cluding azathioprine) taken currently or in previous 30 days
- •Past or present history of psychotic illness.
- •Open/infected pressure sores or other source of chronic infection.
- •Significant fixed tendon contractures.
- •Severe cognitive impairment such that the patient is unable to provide informed consent.
- •History of clinically important renal, cardiovascular or neurol. diseases (apart from MS).
- •Malignancy within the past 2 years.
- •Cannabinoids taken currently or in previous 30 days.
- •Positive qualitative urinary test on cannabinoids at screening visit. (In this case a patient will be allowed to repeat the test at a second screening visit later.)
- •Known hypersensitivity to cannabinoids.
- •Current drug abuse, including alcohol abuse.
- •Laboratory parameters outside the following limits:
- •Creatinine > 3x upper limit of normal Bilirubine > 3x upper limit of normal Transaminases > 5 x upper limit of normal
- •Anticipated immunisations within the 12 weeks of trial participation.
- •Other problems likely to make participation difficult at the discretion of the neurologist.
- •Women who are pregnant, lactating or not using adequate contraception.
- •Participation in other treatment studies currently or within the previous month.
研究组 & 干预措施
1
Cannabis extract (delta-9-THC 2.5mg, CBD 1.25 mg per capsule), flexible dosing between 5 mg and 25 mg THC/d, administered twice daily
干预措施: standardized cannabis extract (Drug)
2
matching placebo capsules, twice daily
干预措施: Placebo (Drug)
结局指标
主要结局
Change in muscle stiffness: 11-point numerical Likert scale
时间窗: 12 weeks
次要结局
- Change in pain: 11-point numerical Likert scale(12 weeks)