A Study of Cannabis Based Medicine Extracts and Placebo in Patients With Pain Due to Spinal Cord Injury
Condition: Pain
MeSH terms: Spinal Cord Injuries
Intervention: GW-1000-02; Placebo
Intervention description: Contained delta-9-tetrahydrocannabinol (THC) (27 mg/ml):cannabidiol (CBD) (25 mg/ml) as extract of Cannabis sativa L., with peppermint oil, 0.05% (v/v), in ethanol:propylene glycol (50:50) excipient. Each actuation delivered 100 μl (THC 2.7 mg and CBD 2.5 mg). The maximum permitted dose of study medication was eight actuations in any three-hour period, and 48 actuations in any 24 hour period.; Contained 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. Each actuation delivered 100 μl. The maximum permitted dose of study medication was eight actuations in any three-hour period, and 48 actuations in any 24 hour period.
Intervention MeSH terms: Nabiximols
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 116.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      A study to investigate the effects of sublingual cannabis based medicine extracts on
      neuropathic pain associated with spinal cord injury.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Gave informed consent for participation in the study.

          -  Male or Female, aged 18 years or above.

          -  Diagnosis of non-acute spinal cord injury, with central neuropathic pain not wholly
             relieved by current therapy.

          -  Central neuropathic pain with a mean severity Numerical Rating Scale score at least
             four during last seven days of the baseline period.

          -  Relatively stable neurology during the preceding six months.

          -  Stable medication regimen during the preceding four weeks.

          -  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.

          -  Had not used cannabinoids for at least the preceding seven days and willing to abstain
             from any use of cannabinoids during the study.

          -  Clinically acceptable laboratory results at Visit 2.

          -  Ability (in the investigator's opinion) and willingness to comply with all study
             requirements.

          -  Agreement for the UK Home Office, their general practitioner, 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.

          -  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 autonomic dysreflexia.

          -  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 therapy within the seven days leading to study entry.

          -  If male, were receiving and were unwilling to stop sildenafil 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.