The effects of nabiximols (Sativex®) on spasticity and non-motor symptoms in chronic spinal cord injury (SCI): a longitudinal prospective study

Spinal Cord Ser Cases. 2025 Jul 17;11(1):19. doi: 10.1038/s41394-025-00712-2.

Abstract

Study design: Observational, longitudinal, prospective study.

Objectives: This study aimed to evaluate the effects of Nabiximols (Sativex®) on spasticity in chronic spinal cord injury (SCI) individuals refractory to conventional therapy. Secondary objectives included assessing its impact on functional independence, neuropathic pain, sleep quality, and depression.

Setting: Institute Guttmann, a neurorehabilitation hospital in Badalona, Catalonia (Spain).

Methods: Adult participants ( >18 years) with chronic SCI ( >6 months) and moderate to severe spasticity refractory to conventional treatments were recruited. All participants underwent baseline assessments and were followed up at one and two months after initiating treatment with nabiximols oromucosal spray, with individualised dose adjustments on a weekly basis. Assessed variables included spasticity, functional independence, neuropathic pain, sleep quality, depression, quality of life, and Patient Global Impression of Improvement (PGI-I).

Results: Statistically significant improvements in spasticity were observed after one month (VAS decrease of 30%, p < 0.001; MAS decrease of 60%, p = 0.001) and two months (VAS decrease of 30%, p < 0.001; MAS decrease of 52%, p = 0.011) of treatment. A positive PGI-I was reported in 67% of participants. However, no significant changes were noted in spasms frequency, functional independence, neuropathic pain, or sleep quality. No significant differences in spasticity change or non-motor symptoms were found between participants with complete and incomplete SCI.

Conclusions: Nabiximols may effectively reduce spasticity in individuals with SCI resistant to conventional therapies. Given the significant impact of spasticity associated with SCI, it could be considered a viable add-on therapy for this population.

Trial registry: This clinical trial is registered in the EudraCT database under the identifier 2022-001777-31.

Sponsorship: Almirall, S.A., Barcelona, Catalonia (Spain).

Publication types

  • Observational Study

MeSH terms

  • Adult
  • Aged
  • Cannabidiol* / administration & dosage
  • Cannabidiol* / therapeutic use
  • Chronic Disease
  • Dronabinol* / administration & dosage
  • Dronabinol* / analogs & derivatives
  • Dronabinol* / therapeutic use
  • Drug Combinations
  • Female
  • Humans
  • Longitudinal Studies
  • Male
  • Middle Aged
  • Muscle Spasticity* / drug therapy
  • Muscle Spasticity* / etiology
  • Neuralgia / drug therapy
  • Neuralgia / etiology
  • Plant Extracts* / administration & dosage
  • Plant Extracts* / therapeutic use
  • Prospective Studies
  • Quality of Life
  • Spinal Cord Injuries* / complications
  • Spinal Cord Injuries* / drug therapy
  • Treatment Outcome

Substances

  • Cannabidiol
  • nabiximols
  • Drug Combinations
  • Dronabinol
  • Plant Extracts