Publications

Below is a list of published papers relating to clinical trials of Sativex. Papers are split into sections and listed in chronological order. GW continues to submit papers for publication on a regular basis and this page will be updated as new publications emerge.

  

Sativex Multiple Sclerosis

 

Sativex long-term use: an open-label trial in patients with spasticity due to multiple sclerosis.

Michael G. Serpell,  William Notcutt, Christine Collin.   J Neurol 2013;260:285-295.

 

A questionnaire survey of patients and carers of patients prescribed Sativex as an unlicensed medicine.

William G. Notcutt. Prim Health Care Res Dev. 2012 Jul 12:1-8.

 

Assessments of blinding to treatment allocation in studies of a cannabis-based medicine (Sativex) in people with multiple sclerosis: a new apporach.

S. Wright, P. Ducombe and  D.G. Altman. Trials 2012; 13:189.  DOI:10.1186/1745-1625-13-189.

 

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.

 

The evaluation of the effects of Sativex (1:1 THC BDS:CBD BDS on the inhibition of spasticity in an experimental model of multiple sclerosis. (Sativex/Baclofen).

A. Hilliard, C. Stott, S.Wright, G. Guy, G. Pryce, S. Al-Izki, C. Bolton, and G. Giovannoni. International Scholarly Research Network ISRN Neurology Volume 2012;2012:802649.

 

Sativex in MS spasticity: a cost-effectiveness model.  

J Slof and A Gras.  Expert Rev. Pharmacoecon. Outcom. Res. 2012; 12 (4), 1-4.

 

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

 

Randomized controlled trial of Sativex to treat detrusor overactivity in multiple sclerosis.

Kavia RB, De Ridder D, Constantinescu CS, Stott CG, Fowler CJ. Mult Scler. 2010 Nov;16(11):1349-59. 

 

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

 

Randomized controlled trial of cannabis-based medicine in spasticity caused by multiple sclerosis.

Collin C, Davies P, Mutiboko IK, Ratcliffe S. European Journal of Neurology. 2007;14:290-6.

 

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.

 

Sativex for the management of multiple sclerosis symptoms.

Perras C.  Issues Emerg Health Technol. 2005 Sep(72):1-4.

 

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

 

Do cannabis-based medicinal extracts have general or specific effects on symptoms in multiple sclerosis? A double-blind, randomized, placebo-controlled study on 160 patients.

Wade DT, Makela P, Robson P, House H, Bateman C. Multiple Sclerosis. 2004;10:1-8.

 

 

Sativex Cancer Pain

 

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.

 

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.

 

Cannabinoids in the management of difficult to treat pain.

Russo EB. Therapeutics and Clinical Risk Management.2008;4(1):245-59.

 

Cannabis, pain, and sleep: lessons from therapeutic clinical trials of Sativex, a cannabis-based medicine.

Russo EB, Guy GW, Robson PJ. Chem Biodivers. 2007 Aug;4(8):1729-43.

 

 

Sativex Neuropathic Pain

 

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.

 

Cannabinoids in the management of difficult to treat pain.

Russo EB. Therapeutics and Clinical Risk Management.2008;4(1):245-59.

 

Cannabis, pain, and sleep: lessons from therapeutic clinical trials of Sativex, a cannabis-based medicine.

Russo EB, Guy GW, Robson PJ. Chem Biodivers. 2007 Aug;4(8):1729-43.

 

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

 

Randomized controlled trial of cannabis medicine in central pain due to multiple sclerosis.

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.

 

 

Sativex Other

 

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.

 

Abuse potential and psychoactive effects of δ-9-tetrahydrocannabinol and cannabidiol oromucosal spray (Sativex), a new cannabinoid medicine.

Robson P.  Expert Opin Drug Saf. 2011 Sep;10(5):675-85. Epub 2011 May 4.

 

Cannabinoid based medicines for neurological disorders – clinical evidence. 

Wright S.  Mol Neurobiology 2007; 36: 129-136

 

A tale of two cannabinoids: The therapeutic rationale for combining tetrahydrocannabinoid and cannabidiol.

Russo EB, Guy GW. Med Hypo. 2006;66:234-246.

 

Combined cannabinoid therapy via na oromucosal spray.

Pérez J. Drugs of Today. 2006;42(8):495-501.

 

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