A randomized, double-blind, placebo-controlled, parallel-group, enriched-design study of nabiximols* (Sativex^®), as add-on therapy, in subjects with refractory spasticity caused by multiple sclerosis

Abstract

The enriched study design provides a method of determining the efficacy and safety of nabiximols in a way that more closely reflects proposed clinical practice, by limiting exposure to those patients who are likely to benefit from it. Hence, the difference between active and placebo should be a reflection of efficacy and safety in the population intended for treatment.

Natural Cannabinoids Improve Dopamine Neurotransmission and Tau and Amyloid Pathology in a Mouse Model of Tauopathy

“…However, very little is known about potential neuroprotective effects of these compounds on complex models of neurodegenerative diseases, which represent the complexity of the human diseases more faithfully. Sativex ® is a cannabinoid-based medicine already approved for the treatment of spasticity in multiple sclerosis [22,23]. Sativex ® is a mixture of 9 -tetrahydrocannabinol (THC) and cannabidiol (CBD).…”

Potencial uso terapéutico de cannabis

“…En este sentido, la activación de los receptores CB1 por parte de cannabis y sus derivados podría tener un efecto beneficioso en la inhibición de la espasticidad. La sinergia analgésica dada por la inhibición de la transmisión del impulso nervioso y el efecto antiespástico que involucra a cannabis y sus derivados en este cuadro, permite que el efecto analgésico neto sea muy efectivo 29,37,41,[43][44][45] . Sin embargo, otros autores presentan resultados contradictorios.…”

Historical overview of the rationale for the pharmacological use of prolonged-release fampridine in multiple sclerosis

“…This symptom is usually addressed with oral baclofen or tizanidine [22], although there are no conclusive data of the functional effects of these treatments in patients with MS [23]. More recently, nabiximols has been used as an add-on therapy for those refractory to conventional antispasticity treatment [24]. In March 2010, the US FDA approved a botulinum A toxin (Botox ® , Allergan Inc.) for focal upper-limb spasticity in disorders including MS.…”