Double-Blind, Placebo-Controlled, Randomized Phase I/IIa Study (Safety and Efficacy) with Buspirone/Levodopa/Carbidopa (SpinalonTM) in Subjects with Complete AIS A or Motor-Complete AIS B Spinal Cord Injury

Abstract

Therefore, this study provides evidence of safety and preliminary efficacy following a single administration of SpinalonTM in subjects with SCI.

Probing the Human Spinal Locomotor Circuits by Phasic Step-Induced Feedback and by Tonic Electrical and Pharmacological Neuromodulation

“…A phase I/IIa study on the effects of Spinalon TM was recently completed in 45 individuals with (motor) complete SCI (see companion paper, [49]). The study was a randomized, placebo-controlled, double-blind dose escalation study.…”

“…In addition to probing the human lumbar spinal circuits through afferent projections activated mechanically or electrically, recent findings introduced the possibility of their pharmacological activation (clinicaltrials.gov/ ct2/show/NCT01484184). Pharmacological stimulation using a specific combination of orally-active molecules (buspirone + levodopa and carbidopa) generated involuntary rhythmic muscle activity and left-right alternating leg movements in paralyzed individuals lying supine, thought to be mediated by CPGs (see companion paper, [49]).…”

Nanofiber Scaffolds as Drug Delivery Systems to Bridge Spinal Cord Injury

“…Recently the association of MP with Rosiglitazione showed an increase in functional recovery with respect to that observed when drugs were administrated alone [ 77 ]. Promising results were obtained for the Buspirone/Levodopa/Carbidopa combination (Spinalon™) in a double-blind randomized study of phase I/IIa involving patients with a complete spinal cord injury according to the American Spinal Injury Association Impairment Scale (AIS) [ 83 ]. Analgesic drugs with a neuropathic-pain target are shown in Table 4 , whereas those effective in neurogenic detrusor activation are listed in Table 5 .…”

Cardiovascular disease and cancer associated with neurological problems: Some hope for innovative combinatorial approaches

“…In other words, therapeutic approaches aimed at restoring or improving regular metabolically-challenging physical activity in patients with SCI shall contribute to reduce the incidence or severity of chronic diseases including CVD and cancer [13,14]. Recent evidence suggests that a drug candidate called Spinalon may be capable of eliciting spinal locomotor neuron activity and, hence, corresponding episodes of involuntary walking on a treadmill in completely paralyzed mice and humans [14,15]. Transdermal electric stimulation has also recently been found to elicit on-demand locomotor-like movements in humans [16].…”