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

Spinal Cord Series and Cases volume 11, Article number: 19 (2025) Cite this article

Subjects

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).

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Fig. 1
Fig. 2: Effects of nabiximols on spasticity in participants with complete and incomplete spinal cord injuries (n = 15).
Fig. 3

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Data availability

The datasets generated during the current study are available from the corresponding author on reasonable request.

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Acknowledgements

We express our gratitude to Dr Gabriele Cattaneo (Institut Guttmann Barcelona) for his valuable assistance in statistical management.

Funding

The medication used for this study was provided by Almirall, S.A., Barcelona, Catalonia (Spain).

Author information

Authors and Affiliations

  1. Fundació Institut Guttmann, Institut Universitari de Neurorehabilitació, Barcelona, Catalonia, Spain

    Fernando Martins Braga, Sergiu Albu, Cecilia Mariño Fernández, Virginia Martínez Santana, Jesús Benito-Penalva & Joan Vidal Samsó

  2. Universitat Autònoma de Barcelona, 08193, Barcelona, Catalonia, Spain

    Fernando Martins Braga, Sergiu Albu, Cecilia Mariño Fernández, Virginia Martínez Santana, Jesús Benito-Penalva & Joan Vidal Samsó

  3. Fundació Institut d’Investigació en Ciències de la Salut Germans Trias i Pujol, Badalona, Catalonia, Spain

    Fernando Martins Braga, Sergiu Albu, Cecilia Mariño Fernández, Virginia Martínez Santana, Jesús Benito-Penalva & Joan Vidal Samsó

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  1. Fernando Martins Braga
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Contributions

Listed authors have met the following authorship criteria: (1) JVS, JBP and SA conceived and designed the work that led to the submission, (2) FMB acquired data, (3) SA, JVS and FMB played an important role in interpreting the results, (4) FMB drafted the paper, (5) JVS, SA, CMF and VMS revised the paper and approved the final version, (6) JVS and FMB agreed to be accountable for all aspects of the work in ensuring that questions related to the accuracy or integrity of any part of the work are appropriately investigated and resolved.

Corresponding author

Correspondence to Fernando Martins Braga.

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Competing interests

The authors declare no competing interests.

Ethics approval and consent to participate

All methods were performed in accordance with the relevant guidelines and regulations. Ethics approval was obtained from the Ethics Committee for Research with Medicinal Products (CEIm) of the Fundació Unió Catalana d’Hospitals, by resolution dated 18 April 2023. This study is registered in the EudraCT database under number 2022-001777-31. Written informed consent was obtained from all participants prior to participation. No identifiable images or personal data of participants are included in this manuscript.

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Martins Braga, F., Albu, S., Mariño Fernández, C. et al. 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 11, 19 (2025). https://doi.org/10.1038/s41394-025-00712-2

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