Aim: This prospective, multicenter, open-label, noninterventional 12-week study investigated the effectiveness and tolerability of add-on nabiximols oromucosal spray (Sativex ® ) in the real-world setting in Germany. Patients & methods: The main analysis set comprised 51 adult patients (49 nabiximols responders) with multiple sclerosis (MS) spasticity. Results: The mean overall goal attainment scale score (primary outcome measure) increased by 46% from baseline to week 12 (35.2 vs 51.4; p < 0.001). Mean gait speed was improved by 23% at 4 and 12 weeks. Clinically meaningful improvements in mean 0-10 numerical rating scale scores for spasticity, pain, sleep quality and urinary bladder dysfunction were recorded at 4 and 12 weeks. Conclusion: Nabiximols is a useful therapeutic option for patients with MS spasticity.
Keyphrases
- multiple sclerosis
- botulinum toxin
- spinal cord injury
- patient reported
- upper limb
- sleep quality
- cerebral palsy
- open label
- end stage renal disease
- mass spectrometry
- white matter
- neuropathic pain
- ejection fraction
- newly diagnosed
- randomized controlled trial
- chronic kidney disease
- depressive symptoms
- systematic review
- ms ms
- chronic pain
- clinical trial
- gestational age
- prognostic factors
- oxidative stress
- physical activity
- pain management
- peritoneal dialysis
- study protocol
- radiation therapy
- single molecule
- psychometric properties