EUCTR2006-004255-38-DE进行中（未招募）不适用
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
适应症
试验速览
- 阶段
- 不适用
- 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
- •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)
- •Inclusion criteria for follow-up phase 3:
- •Complete participation in main study, from visit E1 to visit E20
- •Termination of study phase 2 with visit E20a taking place not more than 7 days later.
- •Exception for all patients with E20 before implementation of Amendment No 11: Termination of study phase 2 with visit E20a taking place not more than 1 month later
- •Exception for all patients with E20 taking place after 31.07.2008 and E20a taking place between December 1st and December 17th, 2008.
- •Treatment is still indicated as per the investigator’s discretion
- •Negative pregnancy test for female patients of childbearing potential at visit E20 or E20a respectively
- •Willingness and capability to pass all required examinations over the entire time of the follow-up phase 3
- •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
- •Exclusion criteria for follow-up phase 3:
- •Critical adverse events during time interval between E20 and E20a including:
- •-Schizoid symptoms
- •-Mania or bipolar affective disorder
- •Abuse of or dependence on Dronabinol
- •Reevaluation of main criteria such as
- •-Advanced renal insufficiency (creatinine >2,2mg/100ml)
- •-Advanced hepatic insuffiency (SGOT/ASAT; SGPT/ALAT >2,5 x upper normal value)
- •-Known severe cardiac diseases (e.g. cardiac insufficiency NYHA IV, severe arrhythmia, severe CHD, myocardial infarction within the last 6 months)
- •-Known HIV-infection
- •-Known alcohol, narcotics or drug abuse
- •-Unwillingness to abstain from use of marihuana
- •-Concurrent participation in other studies
- •-Patients with major peripheral pain syndromes
- •-Legal incompetence or limited legal competence
- •-Patients who do not sign a consent form after thorough medical consultation
研究者
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