Effects of THC/CBD oromucosal spray on spasticity-related symptoms in people with multiple sclerosis: results from a retrospective multicenter study

on behalf of the SA.FE. group, Francesco Patti, Clara Grazia Chisari, Claudio Solaro, Maria Donata Benedetti, Eliana Berra, Assunta Bianco, Roberto Bruno Bossio, Fabio Buttari, Letizia Castelli, Paola Cavalla, Raffaella Cerqua, Gianfranco Costantino, Claudio Gasperini, Angelica Guareschi, Domenico Ippolito, Roberta Lanzillo, Giorgia Teresa Maniscalco, Manuela Matta, Damiano PaolicelliLoredana Petrucci, Simona Pontecorvo, Isabella Righini, Margherita Russo, Francesco Saccà, Giovanna Salamone, Elisabetta Signoriello, Gabriella Spinicci, Daniele Spitaleri, Eleonora Tavazzi, Maria Trotta, Mauro Zaffaroni, Mario Zappia

Research output: Contribution to journalArticlepeer-review


Introduction: The approval of 9-δ-tetrahydocannabinol (THC)+cannabidiol (CBD) oromucosal spray (Sativex®) in Italy as an add-on medication for the management of moderate to severe spasticity in multiple sclerosis (MS) has provided a new opportunity for MS patients with drug-resistant spasticity. We aimed to investigate the improvement of MS spasticity-related symptoms in a large cohort of patients with moderate to severe spasticity in daily clinical practice. Materials and methods: MS patients with drug-resistant spasticity were recruited from 30 Italian MS centers. All patients were eligible for THC:CBD treatment according to the approved label: ≥ 18 years of age, at least moderate spasticity (MS spasticity numerical rating scale [NRS] score ≥ 4) and not responding to the common antispastic drugs. Patients were evaluated at baseline (T0) and after 4 weeks of treatment (T1) with the spasticity NRS scale and were also asked about meaningful improvements in 6 key spasticity-related symptoms. Results: Out of 1615 enrolled patients, 1432 reached the end of the first month trial period (T1). Of these, 1010 patients (70.5%) reached a ≥ 20% NRS score reduction compared with baseline (initial responders; IR). We found that 627 (43.8% of 1432) patients showed an improvement in at least one spasticity-related symptom (SRSr group), 543 (86.6%) of them belonging to the IR group and 84 (13.4%) to the spasticity NRS non-responders group. Conclusion: Our study confirmed that the therapeutic benefit of cannabinoids may extend beyond spasticity, improving spasticity-related symptoms even in non-NRS responder patients.

Original languageEnglish
JournalNeurological Sciences
Publication statusE-pub ahead of print - Apr 1 2020


  • CBD
  • Clinical practice
  • Multiple sclerosis
  • Spasticity-related symptoms
  • THC

ASJC Scopus subject areas

  • Dermatology
  • Clinical Neurology
  • Psychiatry and Mental health


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