Clinical Studies and Case Reports

On this site you will find clinical studies with cannabis or single cannabinoids in different diseases and case reports on the use of cannabis by patients.
You may search for diseases (indications), authors, medication, study design (controlled study, open trial, case report etc.) and other criteria.




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TitleSativex® as Add-on therapy Vs. further optimized first-line ANTispastics (SAVANT) in resistant multiple sclerosis spasticity: a double-blind, placebo-controlled randomised clinical trial.
Author(s)Markovŕ J, Essner U, Akmaz B, Marinelli M, Trompke C, Lentschat A, Silván CV
Journal, Volume, IssueSend to Int J Neurosci. :1-26. [Epub ahead of print]
Major outcome(s)Long-term efficacy of a cannabis spray in the treatment of spasticity due to multiple sclerosis
IndicationMultiple sclerosisAbstract
MedicationOther cannabinoids

Purpose/aim:
To evaluate the efficacy of tetrahydrocannabinol [THC]:cannabidiol [CBD] oromucosal spray (Sativex®) as add-on therapy to optimized standard antispasticity treatment in patients with moderate to severe multiple sclerosis (MS) spasticity.

METHODS:
Sativex as Add-on therapy Vs. further optimized first-line ANTispastics (SAVANT) was a two-phase trial. In Phase A, eligible patients received add-on THC:CBD spray for 4 weeks to identify initial responders (≥ 20% improvement from baseline in spasticity 0-10 numerical rating scale [NRS] score). Following washout, eligible initial responders were randomised to receive THC:CBD spray or placebo for 12 weeks (double-blinded, Phase B). Optimization of underlying antispasticity medications was permitted in both groups across all study periods.

RESULTS:
Of 191 patients who entered Phase A, 106 were randomised in Phase B to receive add-on THC:CBD spray (n = 53) or placebo (n = 53). The proportion of clinically-relevant responders after 12 weeks (&#8805; 30% NRS improvement; primary efficacy endpoint) was significantly greater with THC:CBD spray than placebo (77.4 vs 32.1%; P < 0.0001). Compared with placebo, THC:CBD spray also significantly improved key secondary endpoints: changes in mean spasticity NRS (P < 0.0001), mean pain NRS (P = 0.0013), and mean modified Ashworth's scale (P = 0.0007) scores from Phase B baseline to week 12. Adverse events, when present, were mild/moderate and without new safety concerns.

CONCLUSIONS:
Add-on THC:CBD oromucosal spray provided better and clinically relevant improvement of resistant MS spasticity compared with adjusting first-line antispasticity medication alone.

Route(s)
Dose(s)
Duration (days)
Participants
DesignControlled study
Type of publicationMedical journal
Address of author(s)
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