GW Sativex MS Trials

GW has sponsored clinical trials studying the effect of Sativex on symptoms of MS including; spasticity, neuropathic pain and bladder control. In all of these trials, patients remained on their existing medication during the course of the trial. All symptom relief obtained from Sativex in these trials was over and above any effect achieved by the patients' existing treatments. All completed and published trials are listed below:

Spasticity

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 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.

  

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

 

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 for the management of multiple sclerosis symptoms.

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

 

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.

Bladder Dysfunction

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.

 

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

Neuropathic Pain

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.

 

Other

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.