Safety and Effectiveness of Nabiximols Oromucosal Spray as Add-on Therapy in Participants With Spasticity Due to Multiple Sclerosis

Summary

This trial is being conducted to demonstrate the efficacy of nabiximols, compared with placebo, when added to standard of care, in the treatment of muscle spasms associated with multiple sclerosis (MS).

Timeline

Start

2020-10-01

Primary completion

2023-02-10

Completion

2023-02-28

Outcome

Missed primary endpoint

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

registry analysis (superiority test); Nabiximols vs Placebo; p =0.4263; Difference in least squares means -0.73 (95% CI -2.54 to 1.08) NCT04203498 ↗

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Nabiximols	Other / unclassified	—	Other

Indications