Skip to main content
Log in

The use of medical grade cannabis in Italy for drug-resistant epilepsy: a case series

  • Brief Communication
  • Published:
Neurological Sciences Aims and scope Submit manuscript

Abstract

In Italy, medical grade cannabis (MGC) can be prescribed for different medical conditions, including drug-resistant epilepsy (DRE), once standard and approved therapies have failed, or caused non-tolerable side effects. Here, we present a retrospective case series report of five patients with DRE who started therapy with MGC. Authorized ISO 9001:2008 pharmacies prepared MGC according to Italian laws. Olive oil extracts (OOEs) were prepared following standard extraction protocols, and cannabinoids were measured on each OOE to check for successful extraction.After treatment with MGC, all patients reported a reduction in seizure frequency and severity, and some reported improved mood, sleep quality, and general well-being without relevant side effects. Despite the small sample size and open-label nature of the data, we show that MGC may be successfully used to treat DRE. This is especially true when considering that no valid therapeutic option exists for these patients and that MGC was extremely well tolerated.

This is a preview of subscription content, log in via an institution to check access.

Access this article

Price excludes VAT (USA)
Tax calculation will be finalised during checkout.

Instant access to the full article PDF.

References

  1. Kwan P, Arzimanoglou A, Berg AT, Brodie MJ, Allen Hauser W, Mathern G, Moshé SL, Perucca E, Wiebe S, French J (2010) Definition of drug resistant epilepsy: consensus proposal by the ad hoc task force of the ILAE commission on therapeutic strategies. Epilepsia 51:1069–1077

    Article  CAS  Google Scholar 

  2. Maa E, Figi P (2014) The case for medical marijuana in epilepsy. Epilepsia 55:783–786

    Article  Google Scholar 

  3. Whiting PF, Wolff RF, Deshpande S, Di Nisio M, Duffy S, Hernandez AV, Keurentjes JC, Lang S, Misso K, Ryder S, Schmidlkofer S, Westwood M, Kleijnen J (2015) Cannabinoids for medical use: a systematic review and meta-analysis. JAMA 313:2456–2473

    Article  CAS  Google Scholar 

  4. Decreto Ministeriale 23 gennaio 2013 (13A00942). GU Serie Generale n.33 del 08-02-2013) http://www.gazzettauficiale.it/eli/id/2013/02/08/13A00942/sg (accessed April 10, 2019).

  5. Saccà F, Pane C, Carotenuto A, Massarelli M, Lanzillo R, Florio EB, Brescia MV (2016) The use of medical-grade cannabis in patients non-responders to Nabiximols. J Neurol Sci. 368:349–351

    Article  Google Scholar 

  6. Pacifici R, Marchei E, Salvatore F, Guandalini L, Busardò FP, Pichini S (2018) Evaluation of long-term stability of cannabinoids in standardized preparations of cannabis flowering tops and cannabis oil by ultra-high-performance liquid chromatography tandem mass spectrometry. Clin Chem Lab Med 56:94–96

    Article  CAS  Google Scholar 

  7. Scheffer IE, Berkovic S, Capovilla G, Connolly MB, French J, Guilhoto L, Hirsch E, Jain S, Mathern GW, Moshé SL, Nordli DR, Perucca E, Tomson T, Wiebe S, Zhang YH, Zuberi SM (2017) ILAE classification of the epilepsies position paper of the ILAE Commission for Classification and Terminology. Epilepsia. 58:512–521

    Article  Google Scholar 

  8. Sulak D, Saneto R, Goldstein B (2017) The current status of artisanal cannabis for the treatment of epilepsy in the United States. Epilepsy Behav 70(Pt B):328–333

    Article  Google Scholar 

  9. Laux LC, Bebin EM, Checketts D, Chez M, Flamini R, Marsh ED, Miller I, Nichol K, Park Y, Segal E, Seltzer L, Szaflarski JP, Thiele EA, Weinstock A, CBD EAP study group (2019) Long-term safety and efficacy of cannabidiol in children and adults with treatment resistant Lennox-Gastaut syndrome or Dravet syndrome: expanded access program results. Epilepsy Res 154:13–20

    Article  CAS  Google Scholar 

  10. Marsicano G, Goodenough S, Monory K, Hermann H, Eder M, Cannich A, Azad SC, Cascio MG, Gutiérrez SO, van der Stelt M, López-Rodriguez ML, Casanova E, Schütz G, Zieglgänsberger W, di Marzo V, Behl C, Lutz B (2003) CB1cannabinoid receptors and on-demand defence against excitotoxicity. Science 302(5642):84–88

    Article  CAS  Google Scholar 

  11. Ben-Shabat S, Fride E, Sheskin T, Tamiri T, Rhee MH, Vogel Z, Bisogno T, de Petrocellis L, di Marzo V, Mechoulam R (1998) An entourage effect: inactive endogenous fatty acid glycerol esters enhance 2-arachidonoyl-glycerol cannabinoid activity. Eur J Pharmacol. 353:23–31

    Article  CAS  Google Scholar 

  12. Marchiò M, Roli L, Lucchi C, Costa AM, Borghi M, Iughetti L, Trenti T, Guerra A, Biagini G (2019) Ghrelin plasma levels after 1 year of ketogenic diet in children with refractory epilepsy. Front Nutr 6:112. https://doi.org/10.3389/fnut.2019.00112

    Article  PubMed  PubMed Central  Google Scholar 

Download references

Acknowledgments

The authors are grateful to Ettore Brunello Florio and Annunziata Lombardi for their support on regulatory matters.

Author information

Authors and Affiliations

Authors

Corresponding author

Correspondence to Francesco Saccà.

Ethics declarations

Conflict of interest

The authors report no conflict of interest for the present study.

Ethical approval

This is a retrospective case series report, approved from our local ethics committee.

Statement of informed consent

Informed consents were obtained from patients

Additional information

Publisher’s note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Rights and permissions

Reprints and permissions

About this article

Check for updates. Verify currency and authenticity via CrossMark

Cite this article

Pane, C., Saccà, F. The use of medical grade cannabis in Italy for drug-resistant epilepsy: a case series. Neurol Sci 41, 695–698 (2020). https://doi.org/10.1007/s10072-019-04162-1

Download citation

  • Received:

  • Accepted:

  • Published:

  • Issue Date:

  • DOI: https://doi.org/10.1007/s10072-019-04162-1

Keywords

Navigation