Neurophysiologic Study on Effects of Sativex® on Spasticity in Progressive Multiple Sclerosis
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- H/M reflex ratio
研究概览
简要总结
Aim of this randomized, double-blind, placebo-controlled, cross-over study is to investigate cannabinoid-induced changes in neurophysiological parameters in a group of 40 patients with secondary or primary progressive Multiple Sclerosis (MS).
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
- Double (Participant, Investigator)
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
- •Aged 18 years or above
- •Willing and able to comply with the protocol for the duration of the study
- •Diagnosis of Secondary-Progressive or Primary-Progressive MS from at least 12 months
- •Relapse free from at least 3 months before screening visit
- •Lower limb spasticity
- •EDSS from > 3.0 and < 6.5
- •Moderate to severe spasticity due to MS from at least 6 months and with stable drug treatment not able to relieve symptoms as a whole, deserving a specific add-on treatment
- •Immunomodulatory or immunosuppressant therapies not modified during the study and 6 months before starting the study
- •Stable doses of anti-spasticity agents from at least 2 months prior to screening visit
- •Have given written informed consent
排除标准
- •Any concomitant disease that may cause spasticity or that could interfere with subject's spasticity
- •Botulinum Toxin injection for spasticity in the 4 months prior to screening visit
- •Any known or suspected history of psychotic illness, alcohol or substance abuse, epilepsy, hypersensitivity to cannabinoids
- •Significant cardiac, renal or hepatic disease
- •Female subjects of child bearing potentials and male subjects whose partner is child bearing potential, unless willing to ensure that they or their partner use contraception during the study
- •Female subjects who is pregnant lactating or planning pregnancy during the course of the study and for three months thereafter
- •Sativex® SmPC contraindications
研究组 & 干预措施
first sativex, second placebo
2 weeks first titration period (as per approved SmPC), a 2-week first treatment period (Sativex), a 2-week washout, a cross-over followed by another 2 weeks titration period (as per SmPC), followed by a second 2-week period treatment (placebo)
干预措施: Placebo (Drug)
first placebo, second sativex
2 weeks first titration period (as per approved SmPC), a 2-week first treatment period (placebo), a 2-week washout, a cross-over followed by another 2 weeks titration period (as per SmPC), followed by a second 2-week period treatment (Sativex)
干预措施: Placebo (Drug)
first placebo, second sativex
2 weeks first titration period (as per approved SmPC), a 2-week first treatment period (placebo), a 2-week washout, a cross-over followed by another 2 weeks titration period (as per SmPC), followed by a second 2-week period treatment (Sativex)
干预措施: Sativex® (Drug)
first sativex, second placebo
2 weeks first titration period (as per approved SmPC), a 2-week first treatment period (Sativex), a 2-week washout, a cross-over followed by another 2 weeks titration period (as per SmPC), followed by a second 2-week period treatment (placebo)
干预措施: Sativex® (Drug)
结局指标
主要结局
H/M reflex ratio
时间窗: week 0, 4
To evaluate differences in the H/M ratio scores within subjects affected by progressive MS at baseline and week 4.
次要结局
- Neurophysiology ·H/M ratio ·Transcranial Magnetic Stimulation a) MEP Motor threshold, upper limb b) MEPs amplitudes c) Intracortical facilitation/inhibition (ICI/ICF), upper limb(week 0, 4, 6 and 10)
- Spasticity: ·0-10 11-point numerical spasticity rating scale (NRS) ·Mean modified Ashworth scale (MAS)(week 0, 4, 6, 10)
- Function: ·Timed 25 feet and 10 meters walk ·Hand dexterity measured with 9-HPT(week 0, 4, 6, 10)
- Adverse Events recording(week 0, 4, 6 and 10)
- Other MS Symptoms: ·Sleep Quality NRS ·Pain NRS and Spasm frequency ·Fatigue Severity Scale (FSS)(week 0, 4, 6, 10)