title: THC:CBD Observational Study Data: Evolution of Resistant MS Spasticity and Associated Symptoms.
abstract: BACKGROUND
  The prospective observational MObility ImproVEment (MOVE) 2 study is collecting real-life clinical outcomes data on patients with treatment-resistant multiple sclerosis (MS) spasticity treated with THC:CBD oromucosal spray in routine clinical practice. The MOVE 2 study has been ongoing in Italy, involving more than 30 MS centres across the country, since 2013.
  
  
  METHODS
  Web-based real-time data collection techniques are combined with traditional patients' diaries to capture a wide spectrum of outcomes associated with this innovative cannabis-based medication. After surpassing the recruitment threshold of 300 patients, an interim analysis was performed to determine whether the data collected to date align with those from MOVE 2-Germany and the largest phase III randomized controlled trial (RCT) of THC:CBD oromucosal spray.
  
  
  RESULTS
  In the Italian cohort, THC:CBD oromucosal spray was added mainly to oral baclofen. Similar to MOVE 2-Germany, during 3 months' observation, treatment discontinuations were limited and patients recorded meaningful improvements on the patient-based 0-10 numerical rating scale and physician-rated modified Ashworth scale at mean daily doses that were about one-third lower than those used in the RCT. Also, similar to MOVE 2-Germany, the proportion of patients reporting adverse events was about one-third of the rate recorded in the RCT.
  
  
  CONCLUSIONS
  While MOVE 2-Italy continues, this interim analysis has enabled us to better define the place in therapy of THC:CBD oromucosal spray within the context of daily management of our patients with MS spasticity.
authors.affiliation: Department of Basic Medical Sciences, Neurosciences and Sense Organs, University of Bari, Bari, Italy.
authors.forename: Maria
authors.initials: M
authors.lastname: Trojano
mesh_terms: D000328:Adult; D000588:Amines / Q000627:therapeutic use; D001418:Baclofen / Q000627:therapeutic use; D002121:Calcium Channel Blockers / Q000627:therapeutic use; D002185:Cannabidiol; D015331:Cohort Studies; D003509:Cyclohexanecarboxylic Acids / Q000627:therapeutic use; D013759:Dronabinol; D004338:Drug Combinations; D004359:Drug Therapy, Combination; D005260:Female; D000077206:Gabapentin; D005858:Germany; D006801:Humans; D007558:Italy; D008297:Male; D064086:Medical Marijuana / Q000627:therapeutic use*; D008875:Middle Aged; D009103:Multiple Sclerosis / Q000150:complications / Q000188:drug therapy*; D009125:Muscle Relaxants, Central / Q000627:therapeutic use*; D009128:Muscle Spasticity / Q000188:drug therapy* / Q000209:etiology; D064887:Observational Studies as Topic; D058993:Oral Sprays; D010936:Plant Extracts / Q000627:therapeutic use*; D000069583:Pregabalin / Q000627:therapeutic use; D011446:Prospective Studies; D016896:Treatment Outcome; D005680:gamma-Aminobutyric Acid / Q000627:therapeutic use
chemical_list: D000588:Amines; D002121:Calcium Channel Blockers; D003509:Cyclohexanecarboxylic Acids; D004338:Drug Combinations; D064086:Medical Marijuana; D009125:Muscle Relaxants, Central; D058993:Oral Sprays; D010936:Plant Extracts; D002185:Cannabidiol; D000069583:Pregabalin; D005680:gamma-Aminobutyric Acid; D000077206:Gabapentin; D013759:Dronabinol; D001418:Baclofen; C587251:nabiximols