EUCTR2011-000926-31-CZ进行中（未招募）不适用
A Multicentre, Double-blind, Randomised Parallel Group, Placebo- controlled Study of the Effect of long-term treatment with Sativex onCognitive Function and Mood of Patients with Spasticity due toMultiple Sclerosis
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 120
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
- •Inclusion: Subjects meeting the following criteria will be considered eligible for this study.
- •Subject is aged 18 years or above.
- •Diagnosed with any disease sub-type of MS.
- •Diagnosed with symptomatic spasticity due to MS.
- •Subject has at least moderate spasticity in the opinion of the
- •investigator.
- •Subject fulfils at least one of the two criteria below. Subject must
- •Currently established on a regular dose of anti-spasticity therapy, or
- •Previously tried and failed anti-spasticity therapy.
- •Stable medication regimen for at least 4 weeks prior to study entry,
- •for all medications which may have an effect on spasticity and/or
- •If the subject is taking disease modifying medication this must be at
- •a stable dose for 3 months prior to initial visit.
- •Willing and able to give informed consent.
- •Willing and able to comply with all study requirements.
- •Willing for his or her name to be notified to the responsible
- •authorities for participation in this study, as applicable.
- •Willing to allow his or her primary care practitioner 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: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 60
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 60
排除标准
- •Exclusion: The subject may not enter the study if ANY of the following
- •Any history or immediate family of schizophrenia, other psychotic
- •illness, severe personality disorder or other significant psychiatric
- •disorder other than depression associated with their underlying
- •Any concomitant disease or disorder (such as poorly controlled
- •epilepsy or seizures) that may influence the subject’s level of
- •cognition or mood.
- •Currently using or has used cannabis or cannabinoid-based
- •medications within 30 days of study entry and unwilling to abstain for the duration of the study.
- •Any known or suspected history of a diagnosed dependence
- •disorder, current heavy alcohol consumption (more than 60g of pure alcohol per day [equivalent to a bottle of wine (0.75l) or five glasses of lager (1.5l) or four double liquors] for men, and more than 40g of pure alcohol per day [equivalent of two-thirds of that stated for men] for women), current use of an illicit drug or current non-prescribed use of any prescription drug.
- •Any known or suspected hypersensitivity to cannabinoids or any of
- •the excipients of the Investigational Medicinal Product (IMP)(s).
- •Female subjects of child bearing potential and male subjects whose
- •partner is of child bearing potential, unless willing to ensure that
- •they or their partner use effective contraception during the study
- •and for three months thereafter.
- •Female subject who is pregnant, lactating or planning pregnancy
- •during the course of the study and for three months thereafter.
- •Subjects who have received an IMP within the 12 weeks prior to
- •the initial visit.
- •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.
- •Following a physical examination, the subject has any
- •abnormalities that, in the opinion of the investigator would prevent
- •the subject from safe participation in the study.
- •Subjects previously randomised into this study.
研究者
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