MS Trials Review
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 trials are listed below, together with associated publications and/or press releases where available:
Spasticity
Phase III two phase double-blind, randomised, placebo-controlled, parallel group study of Sativex, in subjects with symptoms of spasticity due to multiple sclerosis. (Ambler Z, Davies P et al. Poster 844 presented at the 25th Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS), 2009). For GW press release, click here.
Phase III double-blind, randomised, placebo-controlled parallel group study of Sativex for the treatment of spasticity in patients with multiple sclerosis. (Collin C et al. European Journal of Neurology. 2007;14:290-6). For GW press release, click here.
Randomised withdrawal trial to assess the maintenance of efficacy after long-term treatment with Sativex for spasticity in MS. (Notcutt W, Davies P et al. Poster 845 presented at the 25th Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS), 2009). For GW press release, click here.
Phase III double-blind, randomised, placebo-controlled parallel group study of Sativex for the treatment of spasticity in patients with multiple sclerosis. (Collin C, Ambler Z et al. Poster 412 presented at the 22nd Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS), 2006). For GW press release, click here.
Meta-analysis of two Phase III studies of Sativex for the treatment of spasticity in patients with multiple sclerosis. (Collin C, Duncombe P. Poster 412 presented at the 22nd Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS), 2006).
Central neuropathic pain
Phase III double-blind, randomised, parallel group, placebo-controlled study of Sativex in central neuropathic pain in multiple sclerosis. (Rog DJ et al. Neurology. 2005;65:812-9).
Phase III double-blind, randomised, parallel group, placebo-controlled study of Sativex in central neuropathic pain in multiple sclerosis. For GW press release, click here.
Randomised withdrawal trial to assess the maintenance of efficacy after long-term treatment with Sativex for central neuropathic pain in MS. For GW press release, click here.
Other MS symptoms
A double-blind, randomised, placebo-controlled, parallel group study of Sativex in patients suffering detrusor overactivity associated with multiple sclerosis. (De Ridder D, Constaninescu C et al. Poster 411 presented at the 22nd Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS), 2006). For GW press release, click here.
A double-blind, randomised, parallel group, placebo-controlled trial of Sativex in patients with multiple sclerosis, followed by an open-label assessment and study extension. (Wade DT et al. Multiple Sclerosis. 2004;10:1-8).
Long term open-label treatment with Sativex in patients with multiple sclerosis. (Constaninescu C, Sarantis N. Poster 410 presented at the 22nd Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS), 2006).