A double-blind, randomized, placebo-controlled, parallel-group study of Sativex, in subjects with symptoms of spasticity due to multiple sclerosis

References

• Rizzo MA, Hadjimichael OC, Preiningerova J, et al. Prevalence and treatment of spasticity reported by multiple sclerosis patients. Mult Scler 2004; 10: 589–595
   PubMed Web of Science ®Google Scholar
• Vukusic S, van Bockstael V, Gosselin S, et al. Regional variationsof multiple sclerosis prevalence in French farmers. J Neurol Neurosurg Psychiatry 2007; 78: 707–709
   PubMed Web of Science ®Google Scholar
• Shakespeare DT, Boggild M, Young C. Anti-spasticity agents for multiple sclerosis. Cochrane Database Syst Rev 2003; (4): CD001332
   Google Scholar
• Smith CR, La Rocca NG, Giesser BS, et al. High-dose oral baclofen: Experience in patients with multiple sclerosis. Neurology 1991; 41: 1829–1831
   PubMed Web of Science ®Google Scholar
• Beard S, Hunn A, Wight J. Treatments for spasticity and pain inmultiple sclerosis: A systematic review. Health Technol Assess 2003; 7: iii, ix—x, 1-111
   Google Scholar
• House of Lords Select Committee on Science and Technology. Cannabis: The Scientific and Medical Evidence, Session 1997-1998, 9th Report, London, UK: Her Majesty's Stationary Office, 1998
   Google Scholar
• GW Pharma Ltd. Product Monograph Sativex® 2005. Available at: http://www.ukcia.org/research/SativexMonograph.pdf
   Google Scholar
• Pertwee RG. Pharmacology of cannabinoid CBI and CB2 receptors. Pharmacol Ther 1997; 74: 129–180
   PubMed Web of Science ®Google Scholar
• Pertwee RG. Neuropharmacology and therapeutic potential of cannabinoids. Addict Biol 2000; 5: 37–46
   PubMed Web of Science ®Google Scholar
• Russo EB, Guy GW. A tale of two cannabinoids: The therapeutic rationale for combining tetrahydrocannabinol and cannabidiol. Med Hypotheses 2006; 66: 234–246
   PubMed Web of Science ®Google Scholar
• Wade D, Makela P, Robson P, et al. 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. Mult Scler 2004; 10: 43/ 141
   Google Scholar
• Collins C, Davies P, Mutiboko 1K, et al. Randomized controlled trial of cannabis-based medicine in spasticity caused by multiple sclerosis. Eur J Neurol 2007; 14: 290–296
   PubMed Web of Science ®Google Scholar
• McCormack HM, Horne DJ, Sheather S. Clinical applications of visual analogue scales: A critical review. Psychol Med 1988; 18: 1007–1019.
   PubMed Web of Science ®Google Scholar
• Farrar JT, Troxel AB, Stott C, et al. Validity, reliability and clinical importance of change in a 0-10 numeric rating scale measure of spasticity: A post-hoc analysis of a randomized, double-blind, placebo-controlled trial. Clin Ther 2008; 30: 974–985
   PubMed Web of Science ®Google Scholar
• Mahoney Fl, Barthel D. Functional evaluation: The Barthel index. Maryland State Med J 1965; 14: 56–61
   Google Scholar
• Collin C, Wade DT, Davies S, et al. The Barthel ADL index: A reliability study. Int Disab Study 1998; 10: 61–63
   Google Scholar
• Bohannon RW, Smith MB. Interrater reliability of a modified Ashworth scale of muscle spasticity. Phys Ther 1987; 67: 206–207
   PubMed Web of Science ®Google Scholar
• Pandyan AD, Johnson GR, Price CI, et al. A review of the properties and limitations of the Ashworth and modified Ashworth scales as measures of spasticity. Clin Rehabil 1999; 13: 373–383
   PubMed Web of Science ®Google Scholar
• The EuroQol Group. EuroQol — a new facility for the measure-ment of health-related quality of life. Health Policy 1990; 16: 199–208
   PubMed Web of Science ®Google Scholar
• Brooks R. EuroQol: The current state of play. Health Policy 1996; 37: 53–72
   PubMed Web of Science ®Google Scholar
• Dolan P. Modeling valuations for EuroQol health states. Med Care 1997; 35: 1095–1108
   PubMed Web of Science ®Google Scholar
• Vickrey BG, Hays RD, Haaroni R, et al. A health-related quality of life measure for multiple sclerosis. Qual Life Res 1995; 4: 187–206
   PubMed Web of Science ®Google Scholar
• Hollis S. Campbell F. What is meant by intention to treat analysis? Survey of published randomized controlled trials. Br Med J 1999; 319: 670–674
   PubMedGoogle Scholar
• Kurtzke JF. Rating of neurological impairment in multiple sclerosis: An expanded disability status scale (EDSS). Neurology 1983; 33: 1444–1452
   PubMed Web of Science ®Google Scholar
• Baker D, Pryce G, Croxford JL, et al. Cannabinoids control spasticity and tremor in a multiple sclerosis model. Nature 2000; 404: 84–87
   PubMed Web of Science ®Google Scholar
• Baker D, Pryce G, Croxford JL, et al. Endocannabinoids control spasticity in a multiple sclerosis model. FASEB J 2001; 15: 300–302
   PubMed Web of Science ®Google Scholar
• Zajicek J, Fox P, Sanders H, et al. Cannabinoids for treatment of spasticity and other symptoms related to multiple sclerosis (CAMS study): Multicentre randomized placebo-controlled trial. Lancet 2003; 362: 1517–1526
   PubMed Web of Science ®Google Scholar
• Zajicek JP, Sanders HP, Wright DE, et al. Cannabinoids in multiple sclerosis (CAMS) study: Safety and efficacy data for 12 months follow up. J Neurol Neurosurg Psychiatry 2005; 76: 1664–1669
   PubMed Web of Science ®Google Scholar
• Wade DT, Robson P, House H, et al. A preliminary controlled study to determine whether whole-plant cannabis extracts can improve intractable neurogenic symptoms. Clin Rehabil 2003; 17: 21–29
   PubMed Web of Science ®Google Scholar
• Wade DT, Makela PM, House H, et al. Long-term use of a cannabis-based medicine in the treatment of spasticity and other symptoms in multiple sclerosis. Mult Scler 2006; 12: 639–645
   PubMed Web of Science ®Google Scholar
• Vaney C, Heinzel-Gutenbrunner M, Jobin P, et al. Efficacy, safety and tolerability of an orally administered cannabis extract in the treatment of spasticity in patients with multiple sclerosis: A randomized, double-blind, placebo-controlled, crossover study. Mult Scler 2004; 10: 417–424
   PubMed Web of Science ®Google Scholar
• Rog DJ, Nurmikko Ti, Friede T, et al. Randomized, controlled trial of cannabis-based medicine in central pain in multiple sclerosis. Neurology 2005; 65: 812–819
   PubMed Web of Science ®Google Scholar
• Berman JS, Symonds C, Birch R. Efficacy of two cannabis based medicinal extracts for relief of central neuropathic pain from brachial plexus avulsion: Results of a randomized controlled trial. Pain 2004; 112: 299–306
   PubMed Web of Science ®Google Scholar
• Rog DJ, Nurmikko Ti, Young CA. Oral delta 9-tetrahydrocanna-binolkannabidiol for neuropathic pain associated with multiple sclerosis: An uncontrolled, open-label, 2-year extension trial. Clin Ther 2007; 9: 2068–2079
   Web of Science ®Google Scholar
• Nurmikko T, Serpell M, Hoggart B, et al. Sativex successfully treats neuropathic pain characterised by allodynia: A randomized, double-blind, placebo-controlled trial. Pain 2007; 133: 210–220.
   PubMed Web of Science ®Google Scholar