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

INTERVENTION:

THC:

CBD, 1:1 and placebo

CONDITION:

Peripheral neuropathic pain, characterised by allodynia ; Signs and Symptoms ; Pain, not elsewhere classified

PRIMARY OUTCOME:

Efficacy in relieving peripheral neuropathic pain after 5 weeks of treatment

SECONDARY OUTCOME:

1. Qualitative aspects of pain as reported the Neuropathic Pain Scale (NPS); 2. The physical and psychological effects of pain using measures of sleep disturbance, the Pain Disability Index (PDI) and General Health Questionnaire (GHQ‐12); 3. Patient?s cognitive function using the Brief Repeatable Battery of Neuropsychological tests (BRB‐N); 4. Patient perception of change in allodynia and pain on movement after 5 weeks of treatment; 5. Tolerability of CBME using the adverse event profile, electrocardiogram (ECG), clinical laboratory tests and vital signs

INCLUSION CRITERIA:

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 h