A Study to Compare Sublingual Cannabis Based Medicine Extracts With Placebo to Treat Brachial Plexus Injury Pain
Condition: Pain
MeSH terms: Marijuana Abuse
Intervention: GW-1000-02; GW-2000-02; Placebo
Intervention description: Contains delta-9-tetrahydrocannabinol (THC) (25 mg/ml) and cannabidiol (CBD) (25mg/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 2.5 mg and CBD 2.5 mg). The maximum daily exposure was set at 48 actuations per day.; Contains THC (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 2.5 mg). The maximum daily exposure was set at 48 actuations per day.; Contains 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 daily exposure was set at 48 actuations per day.
Intervention MeSH terms: Nabiximols
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 48.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      A study to compare the efficacy of two sublingual cannabinoid based medicine extracts with
      placebo in the treatment of chronic pain due to brachial plexus injury.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Aged 18 years or above.

          -  Brachial plexus pain, at least 18 months after the initial injury.

          -  Reported weekly brachial plexus pain at the required severity at Visits 1 and 2; a Box
             Scale-11 pain severity score of four boxes or above.

          -  A pattern of pain that in the Investigator's opinion had been stable during the four
             weeks before study entry.

          -  Stable regular medication during the four weeks before study entry.

          -  A maximum tricyclic antidepressant dose of 75 mg per day, if applicable.

          -  No cannabinoid use (cannabis, Marinol® or Nabilone) at least seven days before study
             entry or during the study.

          -  If sexually active; was either using effective contraception during the study and for
             three months thereafter or had been surgically sterilised or, if female, was
             post-menopausal. All patients agreed to use a barrier method of contraception in
             addition to their usual form of oral or depot contraception.

          -  Willing and able to undertake and comply with all study requirements.

          -  Willing and able to consider and understand the patient information leaflet and
             consent form and to give informed consent. Those patients unable to read or to sign
             the document were managed as detailed in the Declaration of Helsinki.

          -  Willing for his or her general practitioner, and consultant if appropriate, to be
             informed of study participation.

          -  Willing for his or her name to be notified to Home Office for participation in the
             study.

        Exclusion Criteria:

          -  Abuse or strong suspicion of drug abuse, including alcohol or cannabis, or in the
             investigator's opinion had a tendency to drug dependency or substance abuse. Patients
             with a history of abuse could have been included at the discretion of the
             investigator.

          -  Known or suspected adverse reaction to cannabinoids.

          -  Known or suspected hypersensitivity to cannabinoids or any of the excipients of the
             study medication.

          -  History of any type of schizophrenia, any other psychotic illness, or other
             significant psychiatric illness other than depression associated with chronic illness.

          -  Regular levodopa therapy (Sinemet®, Sinemet plus®, Levodopa®, L-dopa®, Madopar®,
             Benserazide®) within seven days of study entry.

          -  Serious cardiovascular disorder including recent angina, uncontrolled hypertension or
             an uncontrolled symptomatic cardiac arrhythmia.

          -  History of significant renal or hepatic impairment as shown in medical history or
             indicated by clinical laboratory results from samples.

          -  History of active epilepsy or convulsions.

          -  Nerve surgery within six months of study entry or any other surgery within two months
             of study entry.

          -  Elective surgery, other procedures requiring general anaesthesia, or a planned
             hospital admission that would have taken place during the study, other than a hospital
             admission under the care of the study investigator.

          -  Terminal illness.

          -  Pregnancy, lactation or expected non-compliance with the contraceptive measures called
             for by the protocol.

          -  Participation in any other pharmacological clinical research study in the 12 weeks
             before study entry.

          -  Planned travel outside the UK between study entry and the end of the crossover phase.