Trial to Evaluate 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 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
Outcome
Missed primary endpoint
registry p = 0.7152; Combined least mean square difference 0.04 (95% CI -0.16 to 0.23) NCT04657666 ↗
paper CONCLUSION: Despite the established efficacy of nabiximols in MSS observed using patient-reported measures, the primary endpoint was not met in this study. PMID 39106541 ↗
release “The RELEASE MSS1 trial did not meet the primary endpoint of change in Lower Limb Muscle Tone-6 (LLMT-6) between baseline and Day 21” jazzpharma.com ↗
release “Phase 3 RELEASE MSS1 trial (NCT04657666) did not meet the primary endpoint of change in Lower Limb Muscle Tone-6 (LLMT-6)” jazzpharma.com ↗
release “Phase 3 RELEASE MSS1 trial (NCT04657666) in multiple sclerosis (MS)-related spasticity did not meet the primary endpoint” jazzpharma.com ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Nabiximols | Other / unclassified | 0.1 ml | Other |
Indications
No indication recorded.