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
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 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 European Journal of Neurology 2011 (Articles online in advance of print)
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.
MS Bladder Dysfunction
Ninety per cent of people with multiple sclerosis (MS) develop lower urinary tract symptoms after 10 years of disease activity.
GW has completed two trials of Sativex in treating bladder dysfunction in people with MS. Details of the trials are listed below:
The first study incorporated 135 patients with advanced MS who were experiencing bladder dysfunction ("Detrusor Overactivity") that was not responding adequately to currently available treatment. In the trial, Sativex achieved statistically significant improvements in a range of bladder symptoms, including nocturia (p= 0.01), daytime frequency (p=0.044), frequency per 24 hours (p=0.001), bladder symptom severity (p=0.001). A significant effect was also seen in the patient's global impression of change (p=0.005). There was also a strong trend in favour of Sativex in urgency (p=0.07). There was no significant effect on incontinence, the primary endpoint of the study. The adverse event data showed the medicine to be generally well tolerated. (Fowler et al. Multiple Sclerosis. 2010; EPub ahead of Print). For GW press release, click here.
Professor Clare Fowler, Professor of Uro-Neurology at the Institute of Neurology, UCL and Consultant in Uro-Neurology, National Hospital for Neurology & Neurosurgery, said, "This study demonstrates that in patients with MS who have exhausted other pharmacological treatments, Sativex improved some of their most troublesome symptoms of bladder dysfunction. The impact that Sativex had, particularly on frequency and nocturia in these patients was of significant benefit for them and was maintained in long-term use. The results suggest that Sativex will have a useful place in the management of these distressing problems."
The results offer promise that bladder dysfunction may provide a further new indication for Sativex in due course. Data from this study is expected to be published in a peer-review journal in the near future.
An earlier open-label pilot study has also been completed involving 21 people with MS to assess the efficacy, safety and tolerability of Sativex for improvements in urinary symptoms; particularly urinary urgency and incontinence. (Brady et al. Multiple Sclerosis. 2004; 10:425-433).
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).