EUCTR2005-005265-11-FR进行中（未招募）1 期
A double blind, randomised, placebo controlled, parallel group study of Sativex® when added to the existing treatment regimen, in the relief of central neuropathic pain in subjects with multiple sclerosis.
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 218
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
- •Subjects meeting the following criteria will be considered eligible for this study:
- •1. Subjects aged 18 years or above.
- •2. Diagnosed with any disease sub-type of multiple sclerosis (MS) of at least two years duration.
- •3. Central neuropathic pain (CNP) due to MS, of at least three months and which is expected to remain stable for the duration of the study.
- •4. Subject has at least moderate CNP, which is defined by: NRS pain scores on all of baseline days B2 to B7 have been recorded, via the IVRS, by the subject and sum to at least 24.
- •5. Subject fulfils at least one of the two criteria below. Subject must be either:
- •- Currently established on a regular dose of analgesic therapy for their CNP
- •- Previously tried and failed or could not tolerate analgesic therapy for their CNP.
- •6. Stable medication regimen for at least 2 weeks prior to study entry, for all medications that may have an affect on neuropathic pain, except paracetamol/acetaminophen.
- •7. Subject is willing to stop taking their own paracetamol/acetaminophen or paracetamol/acetaminophen containing medications and start using study medication paracetamol/acetaminophen as required (prn) for the duration of the study.
- •8. Subject is willing to maintain a stable dose of medications that may have an effect on neuropathic pain, other than study medication and paracetamol/acetaminophen, for the duration of the study.
- •9. If the subject is taking disease modifying medication this must be at a stable dose for 3 months prior to the screening visit.
- •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
- •The subject may not enter the study if ANY of the following apply:
- •1. Subjects whose identified pain is likely to be of a nociceptive, musculoskeletal (including spasms) peripheral neuropathic or psychogenic origin, or is due to trigeminal neuralgia.
- •2. Other pain which is not of a central neuropathic origin thought by the investigator to be of a nature or severity to interfere with the subject’s assessment of neuropathic pain due to MS.
- •3. Subjects medical history suggests that relapses/remission are likely to occur during the study (the next 15 weeks) which are expected to influence the subjects CNP.
- •4. Currently receiving a prohibited medication and unwilling to stop or comply for the duration of the study.
- •5. Currently using or has used recreational cannabis, medicinal cannabis (including Sativex®), or synthetic cannabinoid based medications within 3 months prior to study entry and unwilling to abstain for the duration for the study.
- •6. Any known or suspected history of:
- •- or family history of schizophrenia, other psychotic illness;
- •- alcohol or substance abuse
- •- epilepsy or recurrent seizures
- •- hypersensitivity to cannabinoids
- •7. Significant cardiac, renal or hepatic impairment.
- •8. If female, is pregnant, lactating or planning pregnancy during the course of the study and for three months thereafter.
- •9. Travel outside the country of residence planned during the study.
- •10. Subjects who have received an IMP within the 12 weeks before the screening visit.
研究者
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