In the SAVANT trial, 77.4% of MS patients on add-on THC:CBD spray achieved clinically meaningful spasticity improvement versus 32.1% on optimized standard treatment alone.
MS patients with resistant spasticity, neurologists, and health technology assessors.
77.4% vs 32.1% responder rate
What the researchers found
77.4% of patients receiving add-on THC:CBD spray achieved clinically relevant (30%+) spasticity NRS improvement versus 32.1% on placebo (p<0.0001). THC:CBD spray also significantly improved pain (p=0.0013) and muscle tone on modified Ashworth scale (p=0.0007). Adverse events were mild to moderate.
Why it matters
This trial addressed a practical clinical question: when standard treatments are not working, should clinicians add Sativex or keep adjusting conventional medications? The results strongly favor adding Sativex.
The numbers in context
191 entered Phase A; 106 randomized; 77.4% vs 32.1% responder rate (p<0.0001); pain NRS p=0.0013; modified Ashworth scale p=0.0007; adverse events mild/moderate.
How the study worked
Two-phase enriched-design RCT. Phase A: 191 patients received open-label THC:CBD spray for 4 weeks to identify initial responders (20%+ NRS improvement). Phase B: 106 responders randomized to THC:CBD spray (n=53) or placebo (n=53) for 12 weeks, with underlying antispasticity medication optimization permitted in both groups.
What this study cannot tell us
Enriched design (pre-selected responders in Phase A) inflates apparent efficacy in Phase B. Relatively small Phase B sample (53 per arm). 12-week randomized phase may not capture long-term differences.
How to read the evidence
Strong: double-blind, placebo-controlled RCT with significant results across multiple endpoints.
When this study was published
Published in 2019.
The bigger picture
The SAVANT trial design mirrors real clinical decision-making: a patient has tried standard treatments and they are not working. The magnitude of difference (77% vs 32%) provides strong evidence that THC:CBD spray adds meaningful benefit beyond further medication adjustments.
Questions still open
- What proportion of the original 191 patients responded in Phase A? Does the benefit persist beyond 12 weeks of randomized treatment?
Common questions
How effective is Sativex for MS spasticity?
Does Sativex help with MS pain too?
Read the original research
Sativex® as add-on therapy vs. further optimized first-line ANTispastics (SAVANT) in resistant multiple sclerosis spasticity: a double-blind, placebo-controlled randomised clinical trial.
The International journal of neuroscience, 129(2), 119-128
Citation
Markovà, Jolana; Essner, Ute; Akmaz, Bülent; Marinelli, Marcella; Trompke, Christiane; Lentschat, Arnd; Vila, Carlos. (2019). Sativex® as add-on therapy vs. further optimized first-line ANTispastics (SAVANT) in resistant multiple sclerosis spasticity: a double-blind, placebo-controlled randomised clinical trial.. The International journal of neuroscience, 129(2), 119-128. https://doi.org/10.1080/00207454.2018.1481066
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