Abstract Details

Title Nabiximols Efficacy in Multiple Sclerosis (MS) Spasticity: Treatment Effects on Spasticity Numeric Rating Scale (NRS) and Muscle Spasm Frequency in 2 Randomized Clinical Trials

Topic Neuro-rehabilitation

Presentation(s) P15 - Poster Session 15 (5:30 PM-6:30 PM)

Poster/Presentation
Number 7-002

Background Nabiximols improved spasticity in people with multiple sclerosis (PwMS) in 2 RCTs with enrichment design.

Objective To evaluate the treatment effect of nabiximols during each week of the double-blind, placebo-controlled portion of GWSP0604 and SAVANT using an equivalent statistical model.

Design/Methods Both trials used a 4-week single-blind lead-in Part A to identify initial responders. Participants were randomized in Part B to nabiximols or placebo immediately after Part A in GWSP0604 and after a 4-week washout period in SAVANT. Participants reported Spasticity NRS score (0–10) and spasm frequency daily. Mean 7-day average daily Spasticity NRS score and mean 28-day average daily spasm frequency were assessed. The treatment effect measured as change from Part B baseline in Spasticity NRS score and average daily spasm count was assessed throughout the 12-week Part B treatment period. Incidence of AEs was assessed during Parts A and B.

Results At Part A baseline, mean Spasticity NRS scores were similar for the Part B randomized groups (6.9 to 7.0) (SAVANT [n=106] and GWSP0604 [n=241]). In SAVANT, after the washout period, Part B baseline mean Spasticity NRS scores were 6.9 for the nabiximols and placebo groups. In GWSP0604, Part B baseline mean Spasticity NRS scores were 3.9 for both groups. In both studies, the difference in Spasticity NRS scores favored nabiximols. This effect was significant at all 1-week time points through week 12: -0.52 to -1.97 for SAVANT (all p<0.003 and -0.36 to -0.85 for GWSP0604 [all p<0.007]). Similarly, nabiximols reduced spasm frequency versus placebo at all time points and for all baseline spasm frequency thresholds assessed across the 2 studies: treatment difference of 11% to 37% (all p<0.05). The safety profile of nabiximols was consistent with previous studies.

Conclusions Nabiximols showed significant and sustained treatment effect on Spasticity NRS score and spasm frequency in PwMS and was generally well tolerated.

Authors/Disclosures
Robert Chinnapongse, MD PRESENTER	Dr. Chinnapongse has received personal compensation for serving as an employee of Greenwich Biosciences. Dr. Chinnapongse has stock in Greenwich Biosciences.
	No disclosure on file
Fred D. Lublin, MD, FAAN (Icahn School of Medicine At Mount Sinai)	Dr. Lublin has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Roche/Genentech. Dr. Lublin has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Biogen. Dr. Lublin has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Neurogene. Dr. Lublin has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Novartis. Dr. Lublin has received personal compensation in the range of $10,000-$49,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Medimmune/Viela Bio/Horizon. Dr. Lublin has received personal compensation in the range of $10,000-$49,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Receptos/Celgene/BMS. Dr. Lublin has received personal compensation in the range of $10,000-$49,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Immunic. Dr. Lublin has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Labcorp. Dr. Lublin has received personal compensation in the range of $10,000-$49,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Neuralight. Dr. Lublin has received personal compensation in the range of $10,000-$49,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Entelexo. Dr. Lublin has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Janssen. Dr. Lublin has received personal compensation in the range of $10,000-$49,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Avotres. Dr. Lublin has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Sanofi. Dr. Lublin has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for Biogen. Dr. Lublin has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for EMD Serono. Dr. Lublin has received personal compensation in the range of $100,000-$499,999 for serving as an Expert Witness for Multiple entities. Dr. Lublin has stock in Avotres. Dr. Lublin has stock in Neuralight. The institution of Dr. Lublin has received research support from Brainstorm. The institution of Dr. Lublin has received research support from biogen. The institution of Dr. Lublin has received research support from NIH.
Jacqueline A. Nicholas, MD (OhioHealth Riverside Methodist Hospital)	Dr. Nicholas has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Novartis. Dr. Nicholas has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Genentech. Dr. Nicholas has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Biogen. Dr. Nicholas has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Bristol Myers Squib. Dr. Nicholas has received personal compensation in the range of $500-$4,999 for serving as a Consultant for EMD Serono. Dr. Nicholas has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Novartis. Dr. Nicholas has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Greenwich Biosciences. Dr. Nicholas has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Biogen. Dr. Nicholas has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Genentech. Dr. Nicholas has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for EMD Serono. Dr. Nicholas has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for Genentech. Dr. Nicholas has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Alexion. Dr. Nicholas has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Vielo Bio. Dr. Nicholas has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Bristol Myers Squibb. The institution of Dr. Nicholas has received research support from Novartis. The institution of Dr. Nicholas has received research support from Biogen. The institution of Dr. Nicholas has received research support from Genentech. The institution of Dr. Nicholas has received research support from PCORI. Dr. Nicholas has a non-compensated relationship as a Physician with National MS Society that is relevant to AAN interests or activities. Dr. Nicholas has a non-compensated relationship as a Physician with Siegal Rare Neuroimmune Association that is relevant to AAN interests or activities.
Sylvia Klineova, MD (Icahn School of Medicine At Mount Sinai)	Dr. Klineova has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for EMD Serono. Dr. Klineova has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for Biogen. Dr. Klineova has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Alexion.
	No disclosure on file
	No disclosure on file
Joshua R. Steinerman, MD	Dr. Steinerman has received personal compensation for serving as an employee of Greenwich Biosciences. Dr. Steinerman has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Click Therapeutics. Dr. Steinerman has received stock or an ownership interest from Greenwich Biosciences. Dr. Steinerman has received stock or an ownership interest from Click Therapeutics. Dr. Steinerman has received intellectual property interests from a discovery or technology relating to health care.