A Study to Evaluate the Effects of Cannabis Based Medicine in Patients With Pain of Neurological Origin
Condition: Pain; Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Sclerosis
Intervention: GW-1000-02; Placebo
Intervention description: Each actuation of GW-1000-02 (100 μl) delivered a dose containing 2.5 mg delta-9-tetrahydrocannabinol (THC) and 2.5 mg cannabidiol (CBD). The maximum permitted dose of study medication was eight actuations in any three hour period (20 mg THC/20 mg CBD) and 48 actuations in any 24 hour period (120 mg THC/120 mg CBD).; Each actuation of placebo (100 μl) delivered the excipients only. 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: 70.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      To investigate the ability of a cannabis based medicine extract to relieve chronic refractory
      pain of neurological origin.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patient, or legal representative, willing and able to give informed consent for
             participation in the study.

          -  Male or Female, aged 18 years or above.

          -  Diagnosed with chronic refractory pain due to Multiple Sclerosis or other defects of
             neurological function.

          -  Diagnosed with pain, not wholly alleviated with current analgesic therapy at Visit 1
             and an average score of over 4 on a Box Scale-11 scale on the four consecutive days
             leading up to Visit 2, where: zero = "no pain" and 10 = "worst possible pain".

          -  Stable dose of pain relieving medication for at least two weeks prior to study entry.

          -  Willing to ensure that they or their partner use effective contraception during the
             study and for three months thereafter (applicable to female patients of child bearing
             potential and male patients whose partners were of child bearing potential).

          -  No cannabinoid use (cannabis, Marinol or Nabilone) for at least seven days before
             Visit 1 and be willing to abstain from any use of cannabis during the study.

          -  Able (in the investigator's opinion) and willing to comply with all study
             requirements.

          -  Willing for his or her name to be notified to the Home Office for participation in
             this study.

          -  Willing to allow his or her general practitioner and consultant, if appropriate, to be
             notified of 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.

          -  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.

          -  Female patients who were pregnant, lactating or planning pregnancy during the course
             of the study.

          -  Significant renal or hepatic impairment.

          -  Scheduled elective surgery or other procedures requiring general anaesthesia during
             the study.

          -  Terminally ill or inappropriate for placebo medication.

          -  Any other significant disease or disorder which, in the opinion of the investigator,
             may have put the patient at risk because of participation in the study, or may have
             influenced the result of the study, or the patient's ability to participate in the
             study.

          -  Regular levodopa (Sinemet®, Sinemet Plus®, Levodopa, L-dopa, Madopar®, Benserazide)
             therapy within seven days of study entry.

          -  Known or suspected hypersensitivity to cannabinoids or any of the excipients of the
             study medications.

          -  Known or suspected of having adverse reaction to cannabinoids.

          -  Travel outside the UK planned during the study.

          -  Donation of blood during the study.

          -  Patients who had participated in another research study in the 12 weeks leading up to
             study entry.

          -  Patients who had been previously randomised into this study.

          -  Male patients who were receiving Sildenafil (Viagra®) at the time of study entry and
             were unwilling to stop medication for the duration of the study.