A Study of the Safety and Effectiveness of Sativex®, for the Relief of Symptoms of Spasticity in Subjects, From Phase B, With Multiple Sclerosis (MS)
Condition: Spasticity; Multiple Sclerosis
MeSH terms: Muscle Spasticity; Multiple Sclerosis; Sclerosis
Intervention: Sativex®; Placebo
Intervention description: containing THC (27 mg/ml):CBD (25 mg/ml), in ethanol:propylene glycol (50:50) excipients, with peppermint oil (0.05%) flavouring. Maximum dose within any 24-hour interval is 12 sprays (THC 32.4 mg: CBD 30 mg); containing ethanol:propylene glycol (50:50) excipients, with peppermint oil (0.05%) flavouring and colouring FD&C Yellow No.5 (E102 tartrazine) (0.0260%), FD&C Yellow No.6 (E110 sunset yellow) (0.0038%), FD&C Red No. 40 (E129 Allura red AC) (0.00330%) and FD&C Blue No.1 (E133 Brilliant blue FCF) (0.00058%).
Intervention MeSH terms: Nabiximols
Phase: Phase 3
Study type: Interventional
Primary purpose: Supportive Care
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 572.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Spasticity; Multiple Sclerosis

Summary:

      The purpose of this study is to determine whether Sativex® versus Placebo is effective in the
      relief of symptoms of spasticity in subjects with multiple sclerosis, who have been
      identified as having a capacity to respond to Sativex.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Willing and able to give written informed consent for participation in the study.

          -  Male or female, aged 18 years or above.

          -  Subject is able (in the investigator's opinion) and willing to comply with all study
             requirements.

          -  Diagnosed with any disease sub-type of MS of at least six months duration.

          -  Spasticity due to MS of at least three months duration, which is not wholly relieved
             with current anti-spasticity therapy, and which is expected to remain stable for the
             duration of the study.

          -  Subject 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, or could not tolerate suitable anti-spasticity therapy.

          -  Subject is currently receiving a stable regimen (for at least 30 days prior to study
             entry) of all medications that may have an effect on spasticity; and willing to
             maintain this for the duration of the study. If the subject is currently taking
             disease-modifying medication, this must be at a stable dose for at least three months
             prior to the screening visit; the dose must also remain stable for the duration of the
             study.

          -  Willing for his or her name to be notified to his or her primary care physician, and
             consultant and the responsible authorities for participation in this study, as
             applicable.

        Exclusion Criteria:

          -  Any concomitant disease or disorder that has spasticity-like symptoms or that may
             influence the subject's level of spasticity.

          -  Subject's medical history suggests that relapse/remission is likely to occur during
             the study (over the next 19 weeks) which, in the opinion of the investigator, is
             expected to influence the subject's spasticity.

          -  Currently receiving a prohibited medication and unwilling to stop for the stated
             period prior to the screening visit and for the duration of the study.

          -  Any known or suspected history of: schizophrenia or other psychotic illness;diagnosed
             dependence disorder;poorly controlled epilepsy or recurrent seizures;hypersensitivity
             to cannabinoids.

          -  Significant cardiac, renal or hepatic disease.

          -  Female subjects 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 subject who is pregnant, lactating or planning pregnancy during the course of
             the study or for three months thereafter.

          -  Subjects who have received an IMP within the 12 weeks before Visit 1.

          -  Any other significant disease or disorder which, in the opinion of the investigator,
             may either put the subject at risk because of participation in the study, or may
             influence the result of the study, or the subject's ability to participate in the
             study.

          -  Following a physical examination, the subject has any abnormalities that, in the
             opinion of the investigator, would prevent them from safely participating in the
             study.

          -  Unwilling to abstain from donation of blood during the study.

          -  Travel outside the country of residence planned during the study.

          -  Subjects previously randomised into this study.