Trial to Evaluate the Effect of Nabiximols Oromucosal Spray on Clinical Measures of Spasticity in Participants With Multiple Sclerosis

Phase 3 Completed 68 enrolled Jazz Pharmaceuticals

RandomizedCrossoverTriple-blindTreatment

Summary

This study will be conducted to evaluate the effect of multiple doses of nabiximols as adjunctive therapy compared with placebo on a clinical measure of velocity-dependent muscle tone in the lower limbs (Modified Ashworth Scale Lower Limb Muscle Tone-6 \[MAS LLMT-6\]) in participants with multiple sclerosis (MS) who have not achieved adequate relief from spasticity with other antispasticity medications.

Timeline

Start: 2020-12-21
Primary completion: 2022-05-04
Completion: 2022-05-10

Publications

Bethoux FA, Farrell R, Checketts D, Sahr N, Berwaerts J, Alexander JK, Skobieranda F. 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 Sep;89:105740. doi: 10.1016/j.msard.2024.105740. Epub 2024 Jun 20.

Drugs

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

Indications

No indication recorded.