A Study of Sativex® for Relief of Peripheral Neuropathic Pain Associated With Allodynia.
Condition: Pain; Peripheral Neuropathy
MeSH terms: Neuralgia; Peripheral Nervous System Diseases; Hyperalgesia
Intervention: Sativex®; Placebo
Intervention description: containing THC (27 mg/ml):CBD (25 mg/ml), in ethanol:propylene glycol (50:50) excipients, with peppermint oil (0.05%) flavouring. Maximum permitted dose was eight actuations in any three hour period and 24 actuations (THC 65 mg: CBD 60 mg) in 24 hours; containing peppermint oil, 0.05% (v/v), quinoline yellow, 0.005% (w/v), sunset yellow, 0.0025% (w/v), in ethanol:propylene glycol (50:50) excipient.
Intervention MeSH terms: Nabiximols
Phase: Phase 3
Study type: Interventional
Primary purpose: Supportive Care
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 125.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Pain; Peripheral Neuropathy

Summary:

      The purpose of this study is to evaluate the efficacy of Sativex® compared with placebo in
      relieving peripheral neuropathic pain associated with allodynia.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Willing and able to give informed consent.

          -  Male or female, aged 18 years or above.

          -  Chronic peripheral neuropathic pain of at least six months duration.

          -  Presence of mechanical allodynia within the territory of the affected nerve(s).

          -  Evidence of sensory change in the affected nerve by simple clinical tests.

          -  Peripheral neuropathic pain with a severity score of four or more on at least four
             completed NRS during the baseline week.

          -  Stable dose of analgesic medication for at least two weeks leading to study entry.

          -  Agreement, if female and of child bearing potential or if male with a partner of child
             bearing potential, to ensure that effective contraception was used during the study
             and for three months thereafter.

          -  Have not used cannabinoids (including cannabis, Marinol or Nabilone) for at least
             seven days before Visit 1 and were willing to abstain from any use of cannabinoids
             during the study.

          -  Ability (in the investigator's opinion) and willingness to comply with all study
             requirements.

          -  Agreement for the UK Home Office, their primary care physician, and their consultant
             if appropriate, to be notified of their participation in the study.

        Exclusion Criteria:

          -  History of schizophrenia, other psychotic illness, severe personality disorder or
             other significant psychiatric disorder other than depression associated with their
             underlying condition.

          -  Concomitant severe non-neuropathic pain or the presence of cancer related neuropathic
             pain or neuropathic pain resulting from diabetes mellitus.

          -  Known history of alcohol or substance abuse.

          -  Severe cardiovascular disorder, such as ischaemic heart disease, arrhythmias (other
             than well controlled atrial fibrillation), poorly controlled hypertension or severe
             heart failure.

          -  History of epilepsy.

          -  If female, were pregnant or lactating, or were planning a pregnancy to occur during
             the course of the study.

          -  Significant renal or hepatic impairment.

          -  Elective surgery or other procedures requiring general anaesthesia scheduled to occur
             during the study.

          -  Terminal illness or were considered inappropriate for placebo medication.

          -  Any other significant disease or disorder which, in the opinion of the investigator,
             may have either put the subject at risk because of participation in the study, or may
             influenced the result of the study, or the subject's ability to participate in the
             study.

          -  Regular levodopa (Sinemet®, Sinement Plus®, Levodopa®, L-dopa®, Madopar®,
             Benserazide®) therapy within the seven days leading to study entry.

          -  If male, were receiving and were unwilling to stop sildenafil (Viagra®) for the
             duration of the study.

          -  Known or suspected hypersensitivity to cannabinoids or any of the excipients of the
             study medications.

          -  Known or suspected adverse reaction to cannabinoids.

          -  Intention to travel internationally during the study.

          -  Intention to donate blood during the study.

          -  Participation in another research study in the 12 weeks leading to study entry.

          -  Previous randomisation into this study