630 patients with stable multiple sclerosis and muscle spasticity were randomized to receive oral cannabis extract (n=211), Delta-9-tetrahydrocannabinol (n=206) or placebo (n=213). The purpose of this randomized, double-blind, placebo-controlled trial was to determine whether cannabinoids have a beneficial effect on spasticity, pain and other symptoms characteristic of multiple sclerosis. Cannibinoids did not significantly improve spasticity compared with placebo as assessed by study investigators. There was, however, a significant improvement in patient-reported spasticity, pain, sleep quality and spasms. Self-reported irritability, depression, tiredness, tremor, energy, ability to perform activities of daily living, neurological disability, and general health were not different between groups.