Abstract Details

Title Effect of Nabiximols Cannabinoid Oromucosal Spray on Spasticity and Muscle Strength in Patients with Multiple Sclerosis (MS) Across 3 Randomized Controlled Trials

Topic Multiple Sclerosis

Presentation(s) P10 - Poster Session 10 (5:30 PM-6:30 PM)

Poster/Presentation
Number 9-001

Objective Assess the relationship between spasticity and muscle strength in lower extremities or mobility, using data from 3 RCTs (GWMS0106, GWSP0604, and SAVANT) of nabiximols vs placebo in patients with spasticity due to MS inadequately controlled by antispasticity medications.

Background Spasticity is a common feature of MS especially in patients with long-standing illness. Medications that reduce spasticity may also reduce muscle strength, potentially impairing ability to walk. Patients who do not respond adequately to conventional antispasticity medications need additional treatment options that improve spasticity without causing weakness.

Design/Methods Spasticity was evaluated using the Numerical Rating Scale (NRS) in all 3 trials, muscle strength using Motricity Index (MI) in GWMS0106 and GWSP0604, and mobility using timed 10-m walk (T10MW) test in GWSP0604 and SAVANT. Estimated outcome differences between nabiximols and placebo are summarized. Pearson correlation analysis is being conducted to assess the correlation between spasticity and strength or mobility.

Results This analysis included 184 patients from GWMS0106, 241 from GWSP0604, and 106 from SAVANT. The baseline mean (SD) Expanded Disability Status Scale score was 6.0 (1.42) in GWSP0604 and 5.9 (1.1) in SAVANT. In GWMS0106, nabiximols significantly improved mean NRS spasticity score from baseline vs placebo (-0.52 points [95% CI: -1.029, -0.004]; p=0.048), without significantly affecting the MI for legs (3.86 [-0.06, 7.78]; p=0.054). In GWSP0604, nabiximols significantly improved mean NRS spasticity score from baseline vs placebo (-0.84 [-1.29, -0.40]; p=0.0002), without significantly affecting the MI for legs (0.97 [-1.49, 3.42], p=0.439) or the T10MW test results (-3.34 [-6.95, 0.26]; p=0.069). In SAVANT, nabiximols significantly improved spasticity vs placebo (-1.9 [-2.73, -1.06]; p<0.0001), without significantly affecting the T10MW test results (-1.71 [-3.84, 0.44]; p=0.11).

Conclusions The improvement in spasticity with nabiximols was not accompanied by muscle weakness often observed with antispasticity medications, or by a notable change in preferred walking speed.

Authors/Disclosures
Francois Bethoux, MD (Cleveland Clinic) PRESENTER	No disclosure on file
Kathryn Nichol, PhD (LivaNova)	Dr. Nichol has received personal compensation for serving as an employee of Greenwich Biosciences.
Joanne M. Wagner, PhD, PT	Dr. Wagner has received personal compensation for serving as an employee of Xenon Pharmaceuticals, Inc.. Dr. Wagner has stock in Biogen. Dr. Wagner has stock in Xenon Pharmaceuticals, Inc..
	No disclosure on file
	No disclosure on file
	No disclosure on file

�鶹��ýӳ��

�鶹��ýӳ��

Abstract Details