Tetrahydrocannabinol:Cannabidiol Oromucosal Spray for Multiple Sclerosis-Related Resistant Spasticity in Daily Practice

Eur Neurol. 2016;76(5-6):216-226. doi: 10.1159/000449413. Epub 2016 Oct 13.


Background: Tetrahydrocannabinol:cannabidiol (THC:CBD) oromucosal spray (Sativex®) is an add-on therapy for moderate-to-severe multiple sclerosis (MS)-related drug-resistant spasticity (MSS).

Aim: The MOVE-2 EU study collected data from everyday clinical practice concerning the effectiveness and tolerability of THC:CBD.

Methods: This was an observational, prospective, multicentre, non-interventional study. Patients with resistant MSS prescribed add-on THC:CBD oromucosal spray according to approved labelling, were followed for 3 months. After 1 month, only responders (≥20% improvement in spasticity) continued treatment. The main endpoints were the evolution of MSS and associated symptoms, quality of life (QoL) and tolerability.

Results: Four hundred and thirty three patients (55% female) were recruited (98% in Italy). The mean duration of MSS was 7.4 years and baclofen was used by 78.1% of participants. Three hundred and forty nine participants continued with THC:CBD oromucosal spray after 1 month, and 281 after 3 months. THC:CBD mean dosage was 6 sprays/day. MSS scores and spasticity-related symptoms (spasms, fatigue, pain, sleep quality and bladder dysfunction) were significantly improved by THC:CBD at 3 months, as were activities of daily living, and QoL (EQ-5D VAS). Adverse events, none of which were severe or serious, were reported by 10.4% of patients.

Conclusions: In everyday clinical practice, THC:CBD oromucosal spray provided symptomatic relief of MSS and related troublesome symptoms.

Publication types

  • Multicenter Study
  • Observational Study

MeSH terms

  • Activities of Daily Living
  • Adult
  • Baclofen / therapeutic use
  • Cannabidiol
  • Dronabinol
  • Drug Combinations
  • Female
  • Humans
  • Italy
  • Male
  • Middle Aged
  • Multiple Sclerosis / complications*
  • Multiple Sclerosis / drug therapy
  • Muscle Spasticity / drug therapy*
  • Muscle Spasticity / etiology*
  • Oral Sprays
  • Plant Extracts / administration & dosage*
  • Plant Extracts / adverse effects
  • Prospective Studies
  • Quality of Life


  • Drug Combinations
  • Oral Sprays
  • Plant Extracts
  • Cannabidiol
  • Dronabinol
  • Baclofen
  • nabiximols