Cannabis Spray for Multiple Sclerosis: The Sativex Trial
What Researchers Found About Multiple Sclerosis and Cannabis
The Study at a Glance
Published
European Journal of Neurology, 2011
Researchers
Multiple Sclerosis Center (Czech Republic)
Study Type
Randomized Controlled TrialParticipants
572 patients · 15 weeks
Key Finding
Patients with MS who responded to initial cannabis spray treatment achieved twice the spasticity relief compared to placebo in this large Phase III trial.
Key Finding: Patients with MS who responded to initial cannabis spray treatment achieved twice the spasticity relief compared to placebo in this large Phase III trial.
What Researchers Studied About Multiple Sclerosis and Cannabis
Multiple sclerosis (MS) causes painful muscle spasticity that significantly impacts quality of life. Researchers tested whether a cannabis-based mouth spray (Sativex) could help when other treatments weren't enough.
This Phase III trial was crucial for establishing cannabis as a legitimate treatment option for MS patients.
How This Randomized Controlled Trial Was Conducted
This was a large, rigorous trial with an innovative design:
• Phase A: 572 patients received open-label Sativex for 4 weeks • Responders (≥20% improvement) advanced to Phase B • Phase B: 241 responders randomized to continue Sativex or switch to placebo • 12 additional weeks of double-blind treatment • Spasticity measured using a validated 0-10 scale
Multiple Sclerosis Treatment Results
The Main Results:
- 174% of patients responded positively in the initial open-label phase
- 2Responders who continued Sativex had twice the improvement of placebo
- 3Significant improvements in spasm frequency and sleep quality
- 4Benefits maintained throughout the 12-week randomized phase
- 5Well-tolerated with most side effects being mild (dizziness, fatigue)
By the Numbers
| Statistic | What It Means |
|---|---|
| 74% | responded positively to initial treatment |
| 2x | improvement vs placebo in confirmed responders |
| 572 | patients enrolled in the trial |
| 15 | weeks total study duration |
responded positively to initial treatment
improvement vs placebo in confirmed responders
patients enrolled in the trial
weeks total study duration
What This Means for Multiple Sclerosis Patients
If you have MS with spasticity that hasn't improved enough with standard treatments:
The good news: • About 3 in 4 patients experienced meaningful improvement • Benefits extended beyond spasticity to sleep and quality of life • Sativex is now approved for MS spasticity in many countries
Practical considerations: • Not everyone responds—a trial period helps identify who benefits • Side effects are usually mild but can include dizziness and fatigue • Works best as an add-on to existing treatments, not a replacement
Quick Answers: Multiple Sclerosis and Cannabis
Direct answers based on the findings of this study:
Research Summary: Answers are based on published peer-reviewed studies and represent research findings, not medical recommendations. Individual results may vary. Always consult a healthcare provider before making treatment decisions.
Does marijuana help MS symptoms?
Yes, cannabis helps MS symptoms. A large clinical trial found 74% of MS patients responded to cannabis spray (Sativex) for spasticity, achieving twice the improvement of placebo for muscle stiffness (Novotna et al., 2011).
Source: Novotna et al., European Journal of Neurology, 2011 (PMID: 21449855)
Does cannabis help MS spasticity?
Yes, there is strong evidence. A Phase III trial with 572 patients found 74% responded positively to cannabis spray for MS spasticity, leading to approval in many countries (Novotna et al., 2011).
Source: Novotna et al., European Journal of Neurology, 2011 (PMID: 21449855)
Is MS a qualifying condition for medical marijuana?
Yes, MS qualifies in most states with programs. Multiple sclerosis and conditions causing muscle spasticity qualify for medical marijuana, and a 2011 trial showed 74% of MS patients benefited from cannabis spray.
Source: Novotna et al., European Journal of Neurology, 2011 (PMID: 21449855)
This is educational content, not medical advice
The research summarized here is for informational purposes only. Individual results may vary, and what works in studies may not work the same way for everyone. Always consult with a qualified healthcare provider before making changes to your treatment plan or starting medical cannabis therapy.
Important Limitations
This study has some caveats to keep in mind when interpreting the results:
- Enriched enrollment design (only responders continued) may overestimate effects
- Spasticity measurement relies partly on patient self-report
- Placebo effect may be significant in MS trials
- Not yet FDA-approved in the United States
- Long-term effects beyond 15 weeks not studied
The Bottom Line on Cannabis for Multiple Sclerosis
This large clinical trial showed that cannabis-based medicine (Sativex) significantly helps MS spasticity, especially for patients who show initial response. It represents strong evidence for cannabinoids in treating this challenging symptom.
Do You Qualify for Medical Marijuana?
If you're living with Multiple Sclerosis, you may qualify for a medical marijuana card. Our licensed physicians can evaluate you from home via telehealth.
Related Research & Resources
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Condition Research
Get Your Card
This condition qualifies for medical marijuana in:
Source
Novotna A, Mares J, Ratcliffe S, et al. "A randomized, double-blind, placebo-controlled, parallel-group, enriched-design study of nabiximols (Sativex), as add-on therapy, in subjects with refractory spasticity caused by multiple sclerosis" European Journal of Neurology. 2011. DOI: 10.1111/j.1468-1331.2010.03328.x
Important Information
Study Age: This study was published 15 years ago. Newer research may have updated or refined these findings.
Not Medical Advice: This research summary is for educational purposes only. It should not be used to diagnose, treat, cure, or prevent any disease or medical condition. Always consult a qualified healthcare provider before starting or changing any treatment.
Individual Variation: Research findings represent group averages. Your individual response to cannabis may differ based on genetics, other medications, underlying conditions, and many other factors.
Last reviewed: January 24, 2026
Important Notices
Research Summary Disclaimer
This content represents our interpretation of published scientific research for educational purposes. It should not be used to make treatment decisions without consulting a qualified healthcare provider. Individual results may vary from study findings.
FDA Notice
These statements have not been evaluated by the FDA. Cannabis is not intended to diagnose, treat, cure, or prevent any disease. The FDA has not approved cannabis for any medical condition except specific prescription medications.
Copyright & Fair Use
Research summaries are provided under fair use (17 U.S.C. § 107) for educational purposes. We provide brief summaries with attribution, not full reproductions. All studies remain the intellectual property of their respective authors and publishers.
Data Sources
Study information sourced from PubMed®, U.S. National Library of Medicine. Inclusion does not imply endorsement by NLM, NIH, or the federal government.
For complete information, see our Terms of Use and Research Content Policy.
FAQs: Cannabis for Multiple Sclerosis
Does cannabis help with MS spasticity?
Yes. A large Phase III trial found that 74% of MS patients responded positively to a cannabis-based spray (Sativex), with responders achieving twice the improvement of placebo.
Is MS a qualifying condition for medical marijuana?
Yes. Multiple sclerosis and conditions causing muscle spasticity are qualifying conditions in most states with medical marijuana programs.
What is Sativex?
Sativex is a 1:1 THC/CBD spray. It is a pharmaceutical cannabis spray approved for MS spasticity in many countries though not yet FDA-approved in the US.