PRIMARY STUDY
A randomized, double-blind, placebo-controlled trial to evaluate the effect of nabiximols oromucosal spray on clinical measures of spasticity in patients with multiple sclerosis
Key Findings: Comparing nabiximols for use in treating multiple sclerosis (MS) associated spasticity (MSS) the changes in Modified Ashworth Scale Lower Limb Muscle Tone-6 (MAS LLMT-4) scores from baseline to day 21 also were not significantly different compared to placebo.
Type of Study: Double Blind Clinical Trial
Study Sample Size: 68
Study Result: Inconclusive
Research Location(s): United States
Year of Pub: 2024
Cannabinoids Studied: Cannabidiol (CBD), Tetrahydrocannabinol (THC), Pharma THC:CBD
Phytocannabinoid Source: Not Applicable
Chemotype: Chemotype II
DOSING DETAILS 
Study Dosing Objective: Effective Dose, Safety Profile,
Established Protocol: No effective dose
Route of Administration: Sublingual/Oromucosal
Cannabinoid Ratio: (Pharma THC:CBD : THC : CBD) 1 : 1 : 1 
Dosing Regimen: 1 spray/day to an individually optimized dose, up to a maximum of 12 sprays/day
Titration: 14-day dose titration phase
Treatment Duration: 14-day dose titration phase then a 7-day dose maintenance phase
Clinical Relevance: Nabiximols was not significantly more effective than placebo.
Adverse Events: Safety results in this study were consistent with the known safety profile of nabiximols in patients with multiple sclerosis spasticity.
Additional Notes: Clinical Trial Phase III, Cross-Over
Citation: Bethoux FA, et al. A randomized, double-blind, placebo-controlled trial to evaluate the effect of nabiximols oromucosal spray on clinical measures of spasticity in patients with multiple sclerosis. Mult Scler Relat Disord. 2024; 89:105740. doi: 10.1016/j.msard.2024.105740
Authors: Bethoux FA, Farrell R, Checketts D, Sahr N, Berwaerts J, Alexander JK, Skobieranda F
