EUCTR2006-004255-38-DK进行中（未招募）1 期
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 pain
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 240
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Outpatients aged 18 to 70 years
- •Patients who meet the McDonald diagnostic criteria for definite MS
- •Patients with an EDSS score =3 and =8
- •Outpatients aged 18 to 70 years
- •Patients who meet the McDonald diagnostic criteria for definite MS
- •Patients with an EDSS score =3 and =8
- •Patients who are in a stable phase of MS
- •Patients with MS associated with central neuropathic pain for at least 3 months
- •Patients with central neuropathic pain characterized by pain in a body territory with abnormal sensation to pinprick, touch, or temperature evaluated by the bedside
- •Patients with moderate to severe pain (= pain intensity score of at least ?4 on the 11-point Likert Numerical Rating Scale (NRS) at the maximal pain site)
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Patients experiencing a relapse
- •-within 30 days prior to screening, or
- •-during the run-in phase, or
- •-at randomization
- •Patients with mania or bipolar affective disorder
- •Schizoid symptoms or history of schizophrenia or schizophrenia in the family anamneses
- •Patients with epilepsy
- •Patients with trigeminal neuralgia
- •Patients with severe cardiac diseases
- •Advanced renal insufficiency (creatinine >2,2mg/100ml)
- •Advanced hepatic insufficiency (SGOT/ASAT; SGPT/ALAT >2,5 x upper normal value)
- •Treatment with dronabinol within the last 12 months
- •Use of marihuana within the last 4 weeks and unwillingness to abstain from the use of marihuana for the duration of the study
- •Known hypersensitivity to tramadol and excipients of Tramal® (in Germany and Austria) or Nobligan® (in Denmark) capsules
研究者
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