Evaluation of the Effect of Nabiximols Oromucosal Spray on Clinical Measures of Spasticity in Participants With Multiple Sclerosis

Summary

This study will be conducted to evaluate the effect of multiple doses of nabiximols compared with placebo on a clinical measure of velocity-dependent muscle tone in the lower limbs (Lower Limb Muscle Tone-6 \[LLMT-6\]) in participants with multiple sclerosis (MS). LLMT-6 is defined as the average of the 6 individual Modified Ashworth Scale (MAS)-transformed scores of knee flexors, knee extensors, and plantar flexors on both sides of the body.

Timeline

Start

2021-08-16

Primary completion

2022-11-11

Completion

2022-11-11

Outcome

Met primary endpoint

Stopped (Business): “The study was terminated based on a business decision by the Sponsor.”

registry analysis (superiority test); Nabiximols vs Placebo; p =0.0048; Combined least mean square difference -0.29 (95% CI -0.48 to -0.10); Mixed Models Analysis NCT04984278 ↗

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Nabiximols	Other / unclassified	0.1 ml	Other

Indications