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Study breakdown

SAVANT trial: Add-on Sativex significantly outperformed optimized standard treatment for MS spasticity

Randomized Controlled TrialStrong evidence
The takeaway

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?
In this trial, 77.4% of patients achieved clinically meaningful improvement with add-on Sativex, compared to 32.1% with optimized standard treatment alone.
Does Sativex help with MS pain too?
Yes, the trial found significant improvements in pain scores (p=0.0013) in addition to spasticity improvements.

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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