EUCTR2004-002509-63-GB进行中（未招募）1 期
A double blind, randomised, placebo controlled, parallel group study of Sativex, in subjects with symptoms of spasticity due to multiple sclerosis - N/A
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 284
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
- •1. Subject is willing and able to give informed consent for participation in the study
- •2. Aged 18 years or above
- •3. Subject is able (in the investigators opinion) and willing to comply with all study requirements
- •4. Diagnosed with any disease sub-type of MS of duration of greater than 6 months
- •5. Diagnosed with spasticity due to MS of at least 3 months duration and whose spasticity is not wholly relieved with their current therapy
- •6. If receiving disease modifying medications, these be at a stable dose for at least six months duration prior to the screening visit and willing to maintain this for the duration of the study
- •7. If receiving regular anti-spasticity and non-pharmacological therapies, these be at a stable dose for at least 30 days prior to the screening visit and willing for these to be maintained throughout the study
- •8. The last 6 daily spasticity NRS scores before randomisation (B2 to B7) have been completed and to sum at least 24
- •9. Willing for his or her name to be notified to the responsible authorities for participation in this study, as applicable
- •10. Willing to allow his or her primary care physician and consultant, if appropriate, to be notified of participation in the study
- •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
- •1. Any concomitant disease or disorder that has symptoms of spasticity, or that may influence the subject's level of spasticity
- •2. Currently receiving Botulinum Toxin injections and unwilling to stop for the duration of the study, or has received Botulinum Toxin injection within 4 months prior to the screening visit
- •3. Currently using or has used cannabis within 30 days of study entry and unwilling to abstain for the duration of the study
- •4. Currently using or has used cannabinoid based medications within 60 days of study entry and unwilling to abstain for the durationof the study
- •5. Any history of schizophrenia, other psychotic illness, severe personality disorder or other significant psychiatric disorder other than depression associated with their underlying condition
- •6. Any known history of alcohol or substance abuse
- •7. Any history of epilepsy or recurrent seizures
- •8. Known or suspected hypersensitivity to cannabinoids or any of the excipients of the study medications
- •9. Subject has experienced myocardial infarction or clinically relevant cardiac dysfunction within the last 12 months or has a cardiac disorder that, in the opinion of the investigator would put the subject at risk of a clinically relevant arrhythmia or myocardial infarction
- •10. Subject has a QT interval > 450 ms (males) or > 470 ms (females) as reviewed at the screening visit
- •11. Subject has a secondary tertiary AV block or sinus bradycardia (HR < 50 bpm) or sinus tachycardia (>110 bpm) as reviewed at the screening visit
- •12. Subject has a diastolic blood pressure of < 50 mmHg or > 105 mmHg as reviewed prior to randomisation
- •13. Subject has impaired renal function i.e. serum creatinine clearance is lower than 50ml/min at the screening visit
- •14. Subject has significantly impaired hepatic function in the opinion of the investigator and/or has liver function test values equal to or greater than three times the upper limit of normal
- •15. Following a physical examination has the subject any abnormalities that, in the opinion of the investigator, would prevent the subject from safely participating in the study
- •16. Female subjects of child bearing potential and male subjects whose partner is of child bearing potential, unless willing to ensure they or their partner use contraception during the study and for 3 months thereafter
- •17. Female subject who is pregnant, lactating or planning pregnancy during the course of the study and for 3 months thereafter
- •18. Subjects who have received an Investigational Medicinal Product within the 12 weeks before the screening visit
- •19. Any other significant disease or disorder which, in the opinion of the investigator, may either put the subject at risk because of participation in the study, may influence the result of the study, or the subject's ability to participate in the study
- •20. Travel outside the country of residence planned during the study
- •21. Scheduled elective surgery or other procedures requiring general anaesthesia during the study
- •22. Unwilling to abstain from donation of blood during the study
- •23. Subjects previously randomised into this study
研究者
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