Clinical Trials Overview
A clinical trial is a research study in human volunteers that is carefully designed to answer specific health questions. Over the last decade, clinical trials of Sativex have taken place in many countries across the world, involving over 3,000 people to date. Participation in a clinical trial is a personal decision that should be made in consultation with your doctor.
Sativex Clinical Trials
Sativex Cancer Pain Trials
In August 2007 GW announced the approval (NOC/c) in Canada of Sativex® as adjunctive analgesic treatment in adult patients with advanced cancer who experience moderate to severe pain during the highest tolerated dose of strong opioid therapy for persistent background pain.
GW has completed two Phase II trials with Sativex to date, details of which are provided below. A Phase III programme is now underway. If you are interested in participating in a Sativex clinical trial, please click the link below for details of the current study which is recruiting patients.
Sativex Neuropathic Pain Trials
In April 2005 GW announced its first regulatory approval (NOC/c) for Sativex® in Canada for the symptomatic relief of neuropathic pain in adults with Multiple Sclerosis.
GW has reported positive results from Phase III neuropathic pain trials covering the following indications; central neuropathic pain in MS, allodynia and brachial plexus avulsion. In these trials the patients maintained all their existing analgesic medication in addition to taking the study medication. Therefore symptom relief obtained from Sativex was over and above any effect achieved by the patients existing analgesia.
Sativex Rheumatoid Arthritis Trials
Rheumatoid Arthritis (RA) is a chronic, progressive and disabling auto-immune disease and afflicts up to three per cent of the population in Western countries. It is a very painful condition which can cause severe disability and ultimately affects a person’s ability to carry out everyday tasks.
GW has completed the world’s first controlled trial of a cannabis-based medicine in treating pain due to rheumatoid arthritis (RA), with very encouraging results. Details of this trial are listed below, together with the associated publication.
Sativex Bladder Dysfunction Trials
Ninety per cent of people with multiple sclerosis (MS) develop lower urinary tract symptoms after 10 years of disease activity. GW has completed two trials of Sativex in treating bladder dysfunction in people with MS.
The first study incorporated 135 patients with advanced MS who were experiencing bladder dysfunction ("Detrusor Overactivity") that was not responding adequately to currently available treatment. In the trial, Sativex achieved statistically significant improvements in a range of bladder symptoms, including nocturia (p= 0.01), daytime frequency (p=0.044), frequency per 24 hours (p=0.001), bladder symptom severity (p=0.001). A significant effect was also seen in the patient's global impression of change (p=0.005). There was also a strong trend in favour of Sativex in urgency (p=0.07). There was no significant effect on incontinence, the primary endpoint of the study. The adverse event data showed the medicine to be generally well tolerated.
Professor Clare Fowler, Professor of Uro-Neurology at the Institute of Neurology, UCL and Consultant in Uro-Neurology, National Hospital for Neurology & Neurosurgery, said, "This study demonstrates that in patients with MS who have exhausted other pharmacological treatments, Sativex improved some of their most troublesome symptoms of bladder dysfunction. The impact that Sativex had, particularly on frequency and nocturia in these patients was of significant benefit for them and was maintained in long-term use. The results suggest that Sativex will have a useful place in the management of these distressing problems."
Clinical Trial Publications (Chronological Order)
Michael G. Serpell, William Notcutt, Christine Collin. J Neurol 2013;260:285-295.
A placebo-controlled, parallel-group, randomized withdrawal study of subjects with symptoms of spasticity due to multiple sclerosis who are receiving long-term Sativex® (nabiximols).
Notcutt W, Langford R, Davies P, Ratcliffe S, Potts R. Mult Scler. 2012 Feb;18(2):219-28. Epub 2011 Aug 30.
An Open-Label Extension Study to Investigate the Long-Term Safety and Tolerability of THC/CBD Oromucosal Spray and Oromucosal THC Spray in Patients With Terminal Cancer-Related Pain Refractory to Strong Opioid Analgesics.
Johnson JR, Lossignol D, Burnell-Nugent M, Fallon MT. J Pain Symptom Manage. 2012 Nov 7. pii: S0885-3924(12)00439-3.
Nabiximols for opioid-treated cancer patients with poorly-controlled chronic pain: a randomized, placebo-controlled, graded-dose trial.
Portenoy RK, Ganae-Motan ED, Allende S, Yanagihara R, Shaiova L, Weinstein S, McQuade R, Wright S, Fallon MT. J Pain. 2012 May;13(5):438-49.
A double-blind, randomized, placebo-controlled, parallel-group study of THC/CBD oromucosal spray in combination with the existing treatment regimen, in the relief of central neuropathic pain in patients with multiple sclerosis.
Langford RM, Mares J, Novotna A, Vachova M, Novakova I, Notcutt W, Ratcliffe S. J Neurol. 2012 Nov 21.
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.
Novotna A, Mares J, Ratcliffe S, Novakova I, Vachova M, Zapletalova O, Gasperini C, Pozzilli C, Cefaro L, Comi G, Rossi P, Ambler Z, Stelmasiak Z, Erdmann A, Montalban X, Klimek A, Davies P; Sativex Spasticity Study Group. Eur J Neurol. 2011 Sep;18(9):1122-31
A randomized, double‐blind, placebo‐controlled, crossover study to evaluate the subjective abuse potential and cognitive effects of nabiximols oromucosal spray in subjects with a history of recreational cannabis use.
Schoedel KA, Chen N, Hilliard A, White L, Stott C, Russo E, Wright S, Guy G, Romach MK, Sellers EM. Hum Psychopharmacol. 2011 Apr;26(3):224-36.
Meta-analysis of the efficiacy and safety of Sativex, on spasticity in people with multiple sclerosis.
Wade DT, Collin C, Stott C, Duncombe P. MS 2010;16 (6), 707-714
A double-blind, randomised, placebo-controlled, parallel-group study of Sativex, in subjects with symptoms of spasticity due to multiple sclerosis.
Collin C, Ehler E, Waberzinek G, Alsindi Z, Davies P, Powell K, Notcutt W, O'Leary C, Ratcliffe S, Nováková I, Zapletalova O, Piková J, Ambler Z. Neurological Research, 2010; 32(5), 451-459
Multicenter, double-blind, randomized, placebo-controlled, parallel-group study of the efficacy, safety, and tolerability of THC:CBD extract and THC extract in patients with intractable cancer-related pain.
Johnson JR, Burnell-Nugent M, Lossignol D, Ganae-Motan ED, Potts R, Fallon MT. J Pain Symptom Manage. 2010 Feb;39(2):167-79.
Collin C, Davies P, Mutiboko IK, Ratcliffe S. European Journal of Neurology. 2007;14:290-6.
Oromucosal delta-9 –tetrahrdrocannabinol/cannabidiol for neuropathic pain associated with Multiple Sclerosis: An uncontrolled, open-label, 2-year extension trial.
Rog D, Nurmikko TJ, Young, CA. Clinical Therapeutics. 2007;20(9):2068-2079
Sativex successfully treats neuropathic pain characterised by allodynia: A randomised, double-blind, placebo-controlled clinical trial.
Nurmikko TJ, Serpell MG, Hoggart B, et al. Pain, 2007;133:210-220
Long-term use of a cannabis-based medicine in the treatment of spasticity and other symptoms in multiple sclerosis.
Wade DT, Makela PM, House H, Bateman C, Robson P. Mult Scler. 2006 Oct;12(5):639-45.
Sativex: clinical efficacy and tolerability in the treatment of symptoms of multiple sclerosis and neuropathic pain.
Barnes MP. Expert Opin Pharmacother. 2006 Apr;7(5):607-15.
Preliminary assessment of the efficacy, tolerability and safety of a cannabis-based medicine (Sativex) in the treatment of pain caused by rheumatoid arthritis.
Blake DR, Robson P, Ho M, et al. Rheumatology (Oxford). 2006;45(1):50-2.
An open-label pilot study of cannabis-based extracts for bladder dysfunction in advanced multiple sclerosis.
Brady CM, DasGupta R, Dalton C, et al. Mult Scler. 2004;10(4):425-33
Rog D, Nurmikko T, et al. Neurology. 2005;65:812-819
Efficacy of two cannabis based medicinal extracts for relief of central neuropathic pain from brachial plexus avulsion: results of a randomised controlled trial.
Berman JS, Symonds C, Birch R. Pain. 2004;112:299-306.