A Randomized Study of Sativex on Cognitive Function and Mood: Multiple Sclerosis Patients
Condition: Multiple Sclerosis; Spasticity
MeSH terms: Muscle Spasticity; Multiple Sclerosis; Sclerosis
Intervention: Sativex; Placebo
Intervention description: Patients self-administered their allocated randomized treatment on an outpatient basis, up to a maximum of 12 sprays to the oral mucosa per day (following an initial titration period).; Patients self-administered their allocated randomized treatment on an outpatient basis, up to a maximum of 12 sprays to the oral mucosa per day (following an initial titration period).
Intervention MeSH terms: Nabiximols
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 121.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Cognition; Mood

Summary:

      A study to compare the change in cognitive performance and psychological status of patients
      with spasticity due to Multiple Sclerosis when treated with Sativex or placebo, added to
      existing anti-spasticity therapy over a period of 48 weeks. Secondary objectives were to
      evaluate the effect of Sativex on mood and spasticity and to assess the safety and
      tolerability of Sativex.
    

Eligibility criteria:

        Inclusion Criteria (ALL to be fulfilled):

          -  Patient is willing and able to give informed consent for participation in the study.

          -  Patient is aged 18 years or above.

          -  Diagnosed with any disease sub-type of multiple sclerosis.

          -  Diagnosed with symptomatic spasticity due to multiple sclerosis.

          -  Patient has at least moderate spasticity in the opinion of the investigator.

          -  Patient fulfils at least one of the two criteria below. Subject must be either:

               -  Currently established on a regular dose of anti-spasticity therapy, or

               -  Previously tried and failed anti-spasticity therapy.

          -  Stable medication regimen for at least four weeks prior to study entry, for all
             medications which may have an effect on spasticity and/or cognition.

          -  If the patient is taking disease modifying medication this must be at a stable dose
             for three months prior to the initial visit.

          -  Willing and able to comply with all study requirements.

          -  Willing for his or her name to be notified to the responsible authorities for
             participation in this study, as applicable.

          -  Willing to allow his or her primary care practitioner and consultant, if appropriate,
             to be notified of participation in the study.

        Exclusion Criteria (if ANY apply):

          -  Any history or immediate family of schizophrenia, other psychotic illness, severe
             personality disorder or other significant psychiatric disorder other than depression
             associated with their underlying condition.

          -  Any concomitant disease or disorder (such as poorly controlled epilepsy or seizures)
             that may influence the patient's level of cognition or mood.

          -  Currently using or has used cannabis or cannabinoid-based medications within 30 days
             of study entry and unwilling to abstain for the duration of the study.

          -  Any known or suspected history of a diagnosed dependence disorder, current heavy
             alcohol consumption (more than 60g of pure alcohol per day for men, and more than 40g
             of pure alcohol per day for women), current use of an illicit drug or current
             non-prescribed use of any prescription drug.

          -  Any known or suspected hypersensitivity to cannabinoids or any of the excipients of
             the investigational medicinal products.

          -  Female patients of child bearing potential and male subjects whose partner is of child
             bearing potential, unless willing to ensure that they or their partner use effective
             contraception during the study and for three months thereafter.

          -  Female patient who is pregnant, lactating or planning pregnancy during the course of
             the study and for three months thereafter.

          -  Patients who have received an investigational medicinal product within the 12 weeks
             prior to the initial visit.

          -  Any other significant disease or disorder which, in the opinion of the investigator,
             may either put the patient at risk because of participation in the study may influence
             the result of the study, or the patient's ability to participate in the study.

          -  Following a physical examination, the patient has any abnormalities that, in the
             opinion of the investigator would prevent the patient from safe participation in the
             study.

          -  Previously randomised to this study.