2011 | Multicenter European study | Randomized trial with responder enrichment
Novotna A et al. European Journal of Neurology. 2011;18:1122-1131.
Methods: Of 572 patients entering an initial four-week nabiximols treatment phase, 241 initial responders were randomized to continued THC/CBD oromucosal spray or placebo for 12 weeks. Existing antispasticity treatment continued.
Findings: Among these initial responders, continued nabiximols produced better patient-rated spasticity outcomes than placebo. Several secondary outcomes, including spasm frequency and sleep disturbance, also favored treatment.
Limitations: The randomized sample was deliberately selected for early benefit. Its results should not be presented as the response rate for all people with multiple sclerosis. Symptom improvement does not demonstrate slowed disease progression.