A Study of the Long-term Safety of Sativex Use
Condition: Multiple Sclerosis; Spasticity; Pain
MeSH terms: Multiple Sclerosis
Intervention: GW-1000-02
Intervention description: Contained delta-9-tetrahydrocannabinol (THC) (27 mg/ml) and 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 100 μl actuation of the pump action spray delivered 2.7 mg THC and 2.5 mg CBD. A maximum daily exposure of 130 mg THC was specified by the UK regulatory authority authorisation.
Intervention MeSH terms: Nabiximols
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 507.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      Subjects who had previously received GW-1000-02 in a GW study who opted to continue using it
      in the long-term were monitored for ongoing tolerability and evidence of clinical benefit.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Willing and able to give informed consent.

          -  Male or female aged 18 years or above.

          -  Diagnosed with a condition categorised as one of the following: multiple sclerosis,
             spinal cord conditions, peripheral nerve injury or central nervous system damage
             associated with vascular, traumatic, infective, genetic or metabolic disease and whose
             symptom(s) were not wholly relieved by currently available therapy, prior to the
             previous study of GW-1000-02 or placebo.

          -  Had participated in a GW clinical study using GW-1000-02 within the previous month.

          -  Had shown tolerability to the study medication during the previous GW study.

          -  Was expected, by the investigator, to gain clinical benefit from receiving long-term
             GW-1000-02.

          -  Were willing, if female and of child bearing potential or male subjects 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 (cannabis, Marinol or Nabilone) for at least seven days
             before Visit 1 (the exception being GW-1000-02 given as study medication) and were
             willing to abstain from any use of cannabis during the study.

          -  Recent (within seven days) haematology and blood chemistry that was normal or
             considered clinically acceptable in view of the subjects underlying condition.

          -  Able (in the investigators opinion) and willing to comply with all study requirements.

          -  Willing for the Home Office to be notified of his or her participation in the 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 serious psychiatric illness, including schizophrenia, other psychotic
             illness or severe personality disorder other than depression associated with the
             underlying condition.

          -  Known or strongly suspected of alcohol or substance abuse or considered by the
             investigator to have been at risk 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 or convulsions.

          -  Significant renal or hepatic impairment.

          -  Terminally ill.

          -  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
             have influenced the result of the study, or the subject's ability to participate in
             the study.

          -  Female subjects who were pregnant, lactating or planning pregnancy during the course
             of 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 medication.

          -  Known or suspected adverse reaction to cannabinoids.

          -  Donation of blood during the study.

          -  Previous participation in this study.