title: Influence of Previous Failed Antispasticity Therapy on the Efficacy and Tolerability of THC:CBD Oromucosal Spray for Multiple Sclerosis Spasticity.
abstract: Sativex® (THC:CBD oromucosal spray) is indicated as add-on treatment for patients with moderate to severe multiple sclerosis (MS) spasticity. We aimed to determine whether antispasticity treatment history influenced the efficacy and safety of add-on THC:CBD oromucosal spray in MS spasticity patients.
  
  
  
  Post hoc analysis of an enriched-design clinical trial of THC:CBD oromucosal spray versus placebo, using records of patients under previous and current ineffective antispasticity therapies. Subgroups were patients with at least 1 failed therapy attempt with either baclofen or tizanidine (Group 1) or at least 2 failed therapy attempts with both baclofen and tizanidine (Group 2).
  
  
  
  Of 241 patients in the intent-to-treat population, 162 and 57 patients met the criteria for Groups 1 and 2, respectively. In all groups, response on the spasticity 0-10 Numerical Rating Scale was significantly greater with THC:CBD oromucosal spray versus placebo, for minimal clinically important difference (MCID ≥18% improvement vs. baseline) and clinically important difference (CID, ≥30% improvement vs. baseline). THC:CBD oromucosal spray improved spasticity-related symptoms such as sleep quality and timed 10-meter walk independent of the number of prior failed therapy attempts. Tolerability was not influenced by pre-treatment history.
  
  
  
  THC:CBD oromucosal spray provided consistent relief with good tolerability in MS spasticity patients irrespective of their antispasticity pre-treatment history.
authors.affiliation: Department of Neurology, Augusta Hospital Anholt, Isselburg-Anholt, Germany.
authors.forename: Michael
authors.initials: M
authors.lastname: Haupts
authors.forename: Carlos
authors.initials: C
authors.lastname: Vila
authors.forename: Anna
authors.initials: A
authors.lastname: Jonas
authors.forename: Kerstin
authors.initials: K
authors.lastname: Witte
authors.forename: Lourdes
authors.initials: L
authors.lastname: Álvarez-Ossorio
mesh_terms: D000328:Adult; D001418:Baclofen / Q000627:therapeutic use; D002185:Cannabidiol; D003000:Clonidine / Q000031:analogs & derivatives / Q000627:therapeutic use; D013759:Dronabinol; D004338:Drug Combinations; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009103:Multiple Sclerosis / Q000150:complications* / Q000188:drug therapy; D009128:Muscle Spasticity / Q000188:drug therapy* / Q000209:etiology*; D010276:Parasympatholytics / Q000627:therapeutic use*; D010936:Plant Extracts / Q000627:therapeutic use*
chemical_list: D004338:Drug Combinations; D010276:Parasympatholytics; D010936:Plant Extracts; D002185:Cannabidiol; C023754:tizanidine; D013759:Dronabinol; D001418:Baclofen; C587251:nabiximols; D003000:Clonidine