A double blind, randomised, placebo controlled parallel group study of cannabis based medicine extract (CBME), in the treatment of peripheral neuropathic pain characterised by allodynia

GW Pharma Ltd (UK)0 sites145 target enrollmentNovember 18, 2005

Overview

Registry

who.int

Start Date

November 18, 2005

End Date

March 3, 2004

Last Updated

6 years ago

Study Type

Interventional

Sex

All

Sponsor

GW Pharma Ltd (UK)

•1\. Patient or legal representative is willing and able to give informed consent for participation in the study (if the patient is unable to read or to sign the document, consent procedures as detailed in the Declaration of Helsinki must be followed)
•2\. Male or Female, aged 18 years or above
•3\. Chronic peripheral neuropathic pain of at least 6 months duration
•4\. Presence of mechanical allodynia within the territory of the affected nerve(s)
•5\. Evidence of sensory change in the affected nerve by simple clinical tests
•6\. Pain with a severity score of 4 or more on at least 4 completed BS\-11 scores in the baseline week
•7\. Stable dose of current analgesic medication for at least 2 weeks prior to study entry
•8\. Female patients of child bearing potential and male patients whose partner is of child bearing potential are willing to ensure that they or their partner use effective contraception during the study and for 3 months thereafter
•9\. Willing for his or her names to be notified to the Home Office for participation in this study
•10\. Willing to allow his or her General Practitioner and Consultant, if appropriate, to be notified of participation in the study

•1\. History of schizophrenia, other psychotic illness, severe personality disorder or other significant psychiatric disorder other than depression associated with their underlying condition
•2\. Concomitant severe non\-neuropathic pain or the presence of cancer related neuropathic pain or neuropathic pain resulting from diabetes mellitus
•3\. Known history of alcohol or substance abuse
•4\. Severe cardiovascular disorder, such as ischaemic heart disease, arrhythmias (other than well controlled atrial fibrillation), poorly controlled hypertension or severe heart failure
•5\. History of epilepsy
•6\. Female patient who is pregnant, lactating or planning pregnancy during the course of the study
•7\. Male patient who is currently receiving and unwilling to stop sildenafil (Viagra®) and unwilling to stop for the duration of the study
•8\. Regular levodopa therapy within 7 days of study entry
•9\. Significant renal or hepatic impairment
•10\. Known or suspected hypersensitivity to cannabinoids