THC:CBD Observational Study Data: Evolution of Resistant MS Spasticity and Associated Symptoms

Eur Neurol. 2016;75 Suppl 1:4-8. doi: 10.1159/000444235. Epub 2016 Feb 23.

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.

Publication types

  • Observational Study

MeSH terms

  • Adult
  • Amines / therapeutic use
  • Baclofen / therapeutic use
  • Calcium Channel Blockers / therapeutic use
  • Cannabidiol
  • Cohort Studies
  • Cyclohexanecarboxylic Acids / therapeutic use
  • Dronabinol
  • Drug Combinations
  • Drug Therapy, Combination
  • Female
  • Gabapentin
  • Germany
  • Humans
  • Italy
  • Male
  • Medical Marijuana / therapeutic use*
  • Middle Aged
  • Multiple Sclerosis / complications
  • Multiple Sclerosis / drug therapy*
  • Muscle Relaxants, Central / therapeutic use*
  • Muscle Spasticity / drug therapy*
  • Muscle Spasticity / etiology
  • Observational Studies as Topic
  • Oral Sprays
  • Plant Extracts / therapeutic use*
  • Pregabalin / therapeutic use
  • Prospective Studies
  • Treatment Outcome
  • gamma-Aminobutyric Acid / therapeutic use

Substances

  • Amines
  • Calcium Channel Blockers
  • Cyclohexanecarboxylic Acids
  • Drug Combinations
  • Medical Marijuana
  • Muscle Relaxants, Central
  • Oral Sprays
  • Plant Extracts
  • Cannabidiol
  • Pregabalin
  • gamma-Aminobutyric Acid
  • Gabapentin
  • Dronabinol
  • Baclofen
  • nabiximols