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

Background:  Spasticity is a disabling complication of multiple sclerosis, affecting many patients with the condition. We report the first Phase 3 placebo‐controlled study of an oral antispasticity agent to use an enriched study design.

[1]  D. Wade,et al.  Meta-analysis of the efficacy and safety of Sativex (nabiximols), on spasticity in people with multiple sclerosis , 2010, Multiple sclerosis.

[2]  C. Collin,et al.  A double-blind, randomized, placebo-controlled, parallel-group study of Sativex, in subjects with symptoms of spasticity due to multiple sclerosis , 2010, Neurological research.

[3]  M. Barnes,et al.  A pilot study of a comparison between a patient scored numeric rating scale and clinician scored measures of spasticity in multiple sclerosis. , 2009, NeuroRehabilitation.

[4]  J. Farrar,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. , 2008, Clinical therapeutics.

[5]  R. Moore,et al.  Enriched enrolment with randomised withdrawal (EERW): Time for a new look at clinical trial design in chronic pain , 2008, PAIN.

[6]  C. Collin,et al.  Randomized controlled trial of cannabis‐based medicine in spasticity caused by multiple sclerosis , 2007, European journal of neurology.

[7]  S. Vukusic,et al.  Regional variations in the prevalence of multiple sclerosis in French farmers , 2006, Journal of Neurology, Neurosurgery & Psychiatry.

[8]  D. Wade,et al.  Long-term use of a cannabis-based medicine in the treatment of spasticity and other symptoms in multiple sclerosis , 2006, Multiple sclerosis.

[9]  G. Guy,et al.  A tale of two cannabinoids: the therapeutic rationale for combining tetrahydrocannabinol and cannabidiol. , 2006, Medical hypotheses.

[10]  A. Thompson,et al.  Cannabinoids in multiple sclerosis (CAMS) study: safety and efficacy data for 12 months follow up , 2005, Journal of Neurology, Neurosurgery & Psychiatry.

[11]  T. Vollmer,et al.  Prevalence and treatment of spasticity reported by multiple sclerosis patients , 2004, Multiple sclerosis.

[12]  C. Vaney,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 , 2004, Multiple sclerosis.

[13]  D. Wade,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 , 2004, Multiple sclerosis.

[14]  D. Sackett.  Turning a blind eye:Why we don't test for blindness at the end of our trials , 2004, BMJ : British Medical Journal.

[15]  J. Zajicek,et al.  Cannabinoids for treatment of spasticity and other symptoms related to multiple sclerosis ( CAMS study ) : multicentre randomised placebo-controlled trial , 2022 .

[16]  D. Wade,et al.  A preliminary controlled study to determine whether whole-plant cannabis extracts can improve intractable neurogenic symptoms , 2003, Clinical rehabilitation.

[17]  J. Wight,et al.  Treatments for spasticity and pain in multiple sclerosis: a systematic review. , 2003, Health technology assessment.

[18]  D. Rosielle,et al.  Psychiatry , 1905, NeuroImage.

[19]  A. Makriyannis,et al.  Endocannabinoids control spasticity in a multiple sclerosis model , 2001, FASEB journal : official publication of the Federation of American Societies for Experimental Biology.

[20]  C. Young,et al.  Anti-spasticity agents for multiple sclerosis. , 2001, The Cochrane database of systematic reviews.

[21]  R. Pertwee,et al.  Cannabinoids control spasticity and tremor in a multiple sclerosis model , 2000, Nature.

[22]  R. Pertwee,et al.  Neuropharmacology and therapeutic potential of cannabinoids , 2000, Addiction biology.

[23]  R. Pertwee.  Pharmacology of cannabinoid CB1 and CB2 receptors. , 1997, Pharmacology & therapeutics.