AI Article Synopsis
- Double-blind, randomized, placebo-controlled phase IIA trial tested the safety and pain relief efficacy of NFX-88 in chronic spinal cord injury (SCI) patients.
- A total of 61 adults with varying levels of SCI participated, receiving either a placebo or one of three NFX-88 doses alongside pregabalin.
- Results showed no severe side effects and indicated that the 2.1g/day dose of NFX-88 provided the most significant reduction in neuropathic pain, suggesting its potential for future trials.
Article Abstract
Study Design: Double-blind, randomized, placebo-controlled, parallel-group multicentric phase IIA clinical trial.
Objective: To assess the safety and tolerability of oral administration of NFX-88 in subjects with chronic spinal cord injury (SCI) and explore its efficacy in pain control.
Setting: A total of 7 spinal cord injury rehabilitation units in Spain.
Methods: A total of 61 adult with traumatic complete or incomplete spinal cord injury (C4-T12 level), were randomised 1:1:1:1 to a placebo, NFX88 1.05 g, 2.1 g, 4.2 g/day for up to 12 weeks. The placebo or NFX-88 was administered as add-on therapy to pre-existing pregabalin (150-300 mg per day). Safety and tolerability were evaluated, and the Visual Analogue Scale (VAS) was the primary measure to explore the efficacy of NFX-88 in pain control.
Results: No severe treatment-related adverse effects were reported for any of the four study groups. 44 SCI individuals completed the study and were analysed. The data obtained from the VAS analysis and the PainDETECT Questionnaire (PD-Q) suggested that the combination of NFX88 with pregabalin is more effective than pregabalin with placebo at reducing neuropathic pain (NP) in individuals with SCI and that the dose 2.10 g/day causes the most dramatic pain relief.
Conclusions: NFX88 treatment was found to be highly safe and well tolerated, with the dose of 2.10 g/day being the most effective at causing pain relief. Thus, the promising efficacy of this first-in-class lipid mediator deserves further consideration in future clinical trials.
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| http://www.ncbi.nlm.nih.gov/pmc/articles/PMC11300303 | PMC |
| http://dx.doi.org/10.1038/s41393-024-01006-4 | DOI Listing |
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