Multi-centre, Randomized, Double-blind, Placebo-controlled Study to Investigate the Efficacy and Safety of the Pain Relieving Effect of Dronabinol in Patients With Multiple Sclerosis Associated With Central Neuropathic Pain
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 240
- 试验地点
- 1
- 主要终点
- Mean change of baseline pain severity score on the 11-point Likert Numerical Rating Scale recorded in patient diary
研究概览
简要总结
The purpose of this study is to determine whether Dronabinol is effective and safe in relieving central neuropathic pain in multiple sclerosis patients.
详细描述
Multiple sclerosis (MS) is in all probability an autoimmune disease causing severe neurological disability due to inflammation and degeneration in the central nervous system (CNS). MS affects over 1 million people worldwide. Central neuropathic pain is associated with approximately 30% of all patients with MS. MS-accompanying pain has a major impact on the patients' quality of life as usual conventional analgesics are little effective. The aim of this clinical study is to determine whether Dronabinol is effective and safe in relieving central neuropathic pain in multiple sclerosis patients.
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
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of multiple sclerosis acc. to McDonald diagnostic criteria
- •EDSS score between 3 and 8 (incl.)
- •Patients who are in a stable phase of multiple sclerosis
- •Patients with MS-related central neuropathic pain for at least 3 months
排除标准
- •Severe concomitant diseases
- •Certain concomitant therapies (in particular: pain influencing concomitant therapies)
- •Dronabinol intake within the last 12 months prior to study entry or Marihuana use within one month prior to study entry
研究组 & 干预措施
Dronabinol
干预措施: Dronabinol (Drug)
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Mean change of baseline pain severity score on the 11-point Likert Numerical Rating Scale recorded in patient diary
时间窗: max. 2.5 years
次要结局
- Likert Numerical Rating Scale pain relief(max. 2.5 years)
- Pain-related sleep interference(max. 2.5 years)
- SF-36 (QoL-questionnaire)(max. 2.5 years)
- Intake of rescue medication(48 weeks)