Nabiximols Did Not Reduce Spasticity After Stroke but Appeared Safe for Heart Patients | Research

The takeaway

In a double-blind RCT, nabiximols (Sativex) did not reduce spasticity in stroke patients compared to placebo, but importantly showed no cardiovascular safety concerns in this high-risk population.

Stroke rehabilitation specialists, neurologists, cardiovascular safety researchers

No cardiovascular adverse events in stroke patients

What the researchers found

Among 34 stroke patients, nabiximols did not improve spasticity on the primary or secondary endpoints compared to placebo. However, no cardiovascular adverse events occurred, suggesting cannabis-based treatments may be safe in stroke patients despite theoretical cardiovascular risks.

Why it matters

Nabiximols is approved for MS spasticity but not stroke spasticity. While this trial found no efficacy, the cardiovascular safety finding is significant because stroke patients are typically excluded from cannabis studies due to heart risk concerns.

The numbers in context

41 enrolled, 34 completed; 2 serious adverse events (none cardiovascular); no primary or secondary efficacy endpoints met; crossover design with 1-month phases

How the study worked

Double-blind, randomized, placebo-controlled crossover trial. 41 patients entered, 34 completed. Patients received nabiximols oromucosal spray or placebo for 1 month each, with cardiovascular monitoring throughout.

What this study cannot tell us

Small sample size may have been underpowered to detect effects. Patients had relatively low baseline pain and spasticity levels, which may have limited room for improvement.

How to read the evidence

Well-designed double-blind crossover RCT, but small sample and potentially underpowered.

When this study was published

Published in 2022

The bigger picture

Spasticity mechanisms differ between MS and stroke, which may explain the null finding. The safety data, however, opens the door for further investigation of cannabinoids in stroke patients for other indications.

Questions still open

Would nabiximols work for stroke patients with higher baseline spasticity? Do different spasticity mechanisms between MS and stroke require different cannabinoid approaches?

Common questions

Does nabiximols help with spasticity after stroke?

This RCT found no benefit of nabiximols over placebo for post-stroke spasticity. The authors suggest this may be because spasticity mechanisms differ between stroke and multiple sclerosis, where nabiximols is approved.

Is cannabis safe for stroke patients?

Despite concerns about cardiovascular risks, this study found no cardiovascular adverse events in stroke patients using nabiximols, suggesting it may be safe for this population. This is important because stroke patients are usually excluded from cannabis research.

Read the original research

Cannabinoid Effect and Safety in Spasticity Following Stroke: A Double-Blind Randomized Placebo-Controlled Study.

Frontiers in neurology, 13, 892165

View on PubMed ↗Publisher’s paper ↗

Citation

Marinelli, Lucio; Puce, Luca; Mori, Laura; Leandri, Massimo; Rosa, Gian Marco; Currà, Antonio; Fattapposta, Francesco; Trompetto, Carlo. (2022). Cannabinoid Effect and Safety in Spasticity Following Stroke: A Double-Blind Randomized Placebo-Controlled Study.. Frontiers in neurology, 13, 892165. https://doi.org/10.3389/fneur.2022.892165