title: Nabiximols (THC/CBD oromucosal spray, Sativex®) in clinical practice--results of a multicenter, non-interventional study (MOVE 2) in patients with multiple sclerosis spasticity.
abstract: BACKGROUND
  Nabiximols (Sativex®), a cannabinoid-based oromucosal spray, is an add-on therapy for patients with moderate to severe multiple sclerosis spasticity (MSS) resistant to other medications. The primary objective was to provide real-life observational data of clinical experience of nabiximols in contrast to formal clinical trials of effectiveness.
  
  
  METHODS
  This was an observational, prospective, multicenter, non-interventional study with a follow-up period of 3-4 months, conducted in routine care setting in Germany. Patients with moderate to severe MSS were included at nabiximols' initiation. Structured documentation forms, questionnaires and validated instruments were used for data collection at inclusion, 1 and 3 months after inclusion.
  
  
  RESULTS
  Overall, 335 patients were assessed of whom 276 fitted the criteria and were included in the effectiveness analysis. After 1 month, nabiximols provided relief of resistant MSS in 74.6% of patients according to specialist assessment; mean spasticity 0-10 numerical rating scale (NRS) score decreased from 6.1 ± 1.8 to 5.2 ± 2.0 points; in patients with NRS improvement ≥20% mean NRS score decreased by 40%. After 3 months, 55.3% of patients had continued to use nabiximols and the mean NRS score had decreased by 25% from baseline. 17% of patients reported adverse events.
  
  
  CONCLUSIONS
  Real-life data confirm nabiximols as an effective and well-tolerated treatment option for resistant MSS in clinical practice.
authors: Neurological Rehabilitation Center Quellenhof, Bad Wildbad, Germany.
authors: Peter
authors: P
authors: Flachenecker
authors: Thomas
authors: T
authors: Henze
authors: Uwe K
authors: UK
authors: Zettl
mesh_terms: D000328:Adult; D000368:Aged; D002185:Cannabidiol / Q000009:adverse effects / Q000627:therapeutic use*; D013759:Dronabinol / Q000009:adverse effects / Q000627:therapeutic use*; D004338:Drug Combinations; D005260:Female; D005500:Follow-Up Studies; D005858:Germany; D006801:Humans; D008297:Male; D008875:Middle Aged; D009103:Multiple Sclerosis / Q000188:drug therapy* / Q000503:physiopathology; D009128:Muscle Spasticity / Q000188:drug therapy* / Q000503:physiopathology; D009465:Neuromuscular Agents / Q000009:adverse effects / Q000627:therapeutic use*; D010936:Plant Extracts / Q000009:adverse effects / Q000627:therapeutic use*; D011446:Prospective Studies; D012720:Severity of Illness Index; D012890:Sleep / Q000187:drug effects; D011795:Surveys and Questionnaires; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D004338:Drug Combinations; D009465:Neuromuscular Agents; D010936:Plant Extracts; D002185:Cannabidiol; D013759:Dronabinol; C587251:nabiximols