Cannabinoid Use in Progressive Inflammatory brain Disease - CUPID

Plymouth Hospitals NHS Trust0 个研究点目标入组 492 人开始时间: 2005年12月29日最近更新: 2012年4月3日

试验速览

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•-Primary or secondary progressive MS, assessed according to McDonald criteria.
•-Aged 18 - 65 years.
•-Disease progression (increase in physical disability, not due to major relapses) in preceding year in the opinion of the treating physician.
•-EDSS of 4.0 to 6.5 inclusive.
•-Willing and able to comply with study visits according to protocol for the full study period.
•-Willing to abstain from cannabis use (excluding study medication) for three years.
•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) no
•F.1.3.1 Number of subjects for this age range

•Exclusion criterion:
•-Any immunosuppressive or immunomodulatory therapy received in the previous 12 months.
•-Any experimental therapies with potential disease modifying actions (including stem cells, goat serum and low dose naltrexone) in the previous 12 months.
•-Corticosteroids received in the previous three months.
•-Significant* MS relapse, likely to have had an effect on EDSS, occurring in the previous six months.
•-Predominantly relapsing-remitting disease over the previous 12 months.
•-Other serious illness or medical condition likely to interfere with study assessment, including ischaemic heart disease or evidence of chronic infection from any source, including pressure sores.
•-Previous history of psychotic illness.
•-Sesame seed allergy.
•-Severe cognitive impairment such that patient is unable to provide informed consent.
•-Women who are pregnant, breast-feeding or planning a pregnancy within the next three years.
•-Cannabinoids (including Nabilone) taken in previous four weeks (negative urinalysis required).
•-Participation in another interventional study within the last three months.
•-Any other factor that might interfere with long-term study compliance in the opinion of the local research team.

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