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Objective The aim of the present observational study was to determine the effects of a delta-9-tetrahydrocannabinol ( THC) and cannabidiol ( CBD) oromucosal spray (Sativex® spray), brand name Sativex®, indicated for drug-resistant MS spasticity, on the driving ability of treated MS patients. Methods The study was conducted over a period of 4-6 weeks. Thirty-three MS patients with moderate to severe treatment-resistant spasticity and planned to begin add-on treatment with Sativex® were enrolled at three specialized MS centres in Germany. A set of five driving test procedures from a validated computerized test battery was used to evaluate the driving ability of eligible patients. Tests were performed by patients at baseline and repeated after 4-6 weeks of treatment with Sativex® oromucosal spray. According to German normative data, the test thresholds achieved by the general population served as a reference to allow for a fitness/unfitness to drive classification. Results Patients showed comparable driving test results at baseline and at final visits. Only two patients changed classification shifting from 'unfit' to drive to 'fit' and vice versa. The mean severity of spasticity, as self-reported by the patients, improved with statistical significance. Sativex® was generally well tolerated. Conclusions Treatment of MS patients with Sativex® does not negatively impact on driving ability and may improve moderate to severe treatment-resistant MS spasticity. [ABSTRACT FROM AUTHOR]