SAVANT trial: Add-on Sativex significantly outperformed optimized standard treatment for MS spasticity
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.
Quick Facts
What This Study 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.
Key Numbers
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 They Did This
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.
Why This Research 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 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.
What This Study Doesn't 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.
Questions This Raises
- ?What proportion of the original 191 patients responded in Phase A?
- ?Does the benefit persist beyond 12 weeks of randomized treatment?
Trust & Context
- Key Stat:
- 77.4% vs 32.1% responder rate
- Evidence Grade:
- Strong: double-blind, placebo-controlled RCT with significant results across multiple endpoints.
- Study Age:
- Published in 2019.
- Original Title:
- 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.
- Published In:
- The International journal of neuroscience, 129(2), 119-128 (2019)
- Authors:
- Markovà, Jolana, Essner, Ute(2), Akmaz, Bülent, Marinelli, Marcella, Trompke, Christiane, Lentschat, Arnd, Vila, Carlos
- Database ID:
- RTHC-02158
Evidence Hierarchy
Participants are randomly assigned to treatment or placebo groups to test cause and effect.
What do these levels mean? →Frequently Asked 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 More on RethinkTHC
- CBD-oil-quality-guide
- anxiety-medication-after-quitting-weed
- cannabis-chemotherapy-nausea
- cannabis-chronic-pain-research
- cannabis-epilepsy-CBD-Epidiolex
- cbd-anxiety-research-evidence
- cbd-for-weed-withdrawal
- cbd-vs-thc-difference
- medical-benefits-of-cannabis
- quitting-weed-before-surgery
- quitting-weed-medication-interactions
- quitting-weed-pregnancy
- quitting-weed-pregnant
- seniors-older-adults-cannabis-risks-medications
- weed-breastfeeding-THC-breast-milk
Cite This Study
https://rethinkthc.com/research/RTHC-02158APA
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
MLA
Markovà, Jolana, et al. "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, 2019. https://doi.org/10.1080/00207454.2018.1481066
RethinkTHC
RethinkTHC Research Database. "Sativex® as add-on therapy vs. further optimized first-line ..." RTHC-02158. Retrieved from https://rethinkthc.com/research/markova-2019-sativex-as-addon-therapy
Access the Original Study
Study data sourced from PubMed, a service of the U.S. National Library of Medicine, National Institutes of Health.
This study breakdown was produced by the RethinkTHC research team. We analyze and report published research findings without making health recommendations. All interpretations are based solely on the published abstract and study data.