drugset / Trial / NCT04984278

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

NCT04984278

Phase 3 Terminated 56 enrolled Jazz Pharmaceuticals
RandomizedCrossoverTriple-blindTreatment

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

Drugs

EvaluationDrugModalityDoseRoute
Subject Nabiximols Other / unclassified 0.1 ml Other

Indications