A Study to Evaluate the Efficacy of Sativex in Relieving Symptoms of Spasticity Due to Multiple Sclerosis

Inclusion Criteria: * Willing and able to give informed consent. * Aged 18 years or above. * Ability (in the investigator's opinion) and willingness to comply with all study requirements. * Diagnosed with any disease subtype of multiple sclerosis of duration greater than six months. * Diagnosed with spasticity due to multiple sclerosis of at least three months duration and was not wholly relieved with their current therapy. * Stable dose of anti-spasticity and non-pharmacological therapies for at least 30 days prior to the screening visit and willingness for these to be maintained for the duration of the study. * Stable dose of disease modifying medications for at least six months duration prior to the screening visit and willingness to maintain this for the duration of the study. * The last six daily diary spasticity numerical rating scale scores before randomisation had been completed and summed to at least 24. * Agreement for the responsible authorities (as applicable in individual countries), their primary care physician, and their consultant, if appropriate, to be notified of their participation in the study. Exclusion Criteria: * Concomitant disease or disorder that had symptoms of spasticity, or that may have influenced the subject's level of spasticity. * Received a Botulinum Toxin injection within four months prior to the screening visit or unwillingness to stop receiving Botulinum Toxin injections for the relief of spasticity for the duration of the study. * Had …