Randomised, double-blind, placebo-controlled, parallel-group, multicentric, phase IIA clinical trial for evaluating the safety, tolerability, and therapeutic efﬁcacy of daily oral administration of NFX88 to treat neuropathic pain in individuals with spinal cord injury

Spinal Cord, 2024 · DOI: https://doi.org/10.1038/s41393-024-01006-4 · Published: June 19, 2024

Spinal Cord Injury Pain Management Research Methodology & Design

Simple Explanation

This study investigates a new drug, NFX88, for treating neuropathic pain in people with spinal cord injuries. The study tested different doses of NFX88 to see if it was safe and if it helped reduce pain. Participants were given either a placebo or NFX88 in addition to their existing pain medication (pregabalin). The researchers monitored side effects and measured pain levels to see how well the drug worked. The results showed that NFX88 was safe and well-tolerated, and there was some evidence that it could reduce neuropathic pain, especially at a dose of 2.10 g/day. Further studies are needed to confirm these findings.

Study Duration

12 weeks treatment, ~17 weeks total

Participants

61 adults with traumatic complete or incomplete spinal cord injury (C4-T12 level)

Evidence Level

Level II: Phase IIA randomised, double-blind, placebo-controlled, parallel-group, and multi-centric trial

Key Findings

1
NFX88 treatment was found to be highly safe and well tolerated in individuals with spinal cord injury.
2
The data suggested that NFX88 with pregabalin is more effective than pregabalin with placebo at reducing neuropathic pain in individuals with SCI.
3
The dose of 2.10 g/day of NFX88 appeared to cause the most dramatic pain relief.

Research Summary

This study was a phase IIA clinical trial designed to assess the safety, tolerability, and preliminary efficacy of NFX88 in treating neuropathic pain in individuals with spinal cord injury. The trial involved 61 participants who were randomized to receive either a placebo or one of three different doses of NFX88 (1.05 g, 2.1 g, or 4.2 g) daily for 12 weeks, in addition to pregabalin. The results indicated that NFX88 was safe and well-tolerated, and there was evidence suggesting that the 2.1 g/day dose may be the most effective at reducing neuropathic pain. Further research is warranted.

Practical Implications

Potential New Treatment Option

NFX88 could provide a new therapeutic option for managing neuropathic pain in SCI patients, especially for those who do not respond well to current treatments.

Further Clinical Trials

The promising efficacy of NFX88, particularly at the 2.10 g/day dose, warrants further investigation in larger, Phase IIB/III clinical trials.

Combination Therapy

NFX88 may be effectively used in combination with pregabalin to provide enhanced pain relief for SCI individuals.

Study Limitations

1
The sample size was underpowered to demonstrate efﬁcacy; therefore, we must consider the results for efﬁcacy to be only exploratory.
2
The exclusion criteria used, for example, limit our ability to generalize these ﬁndings to central neuropathic pain of aetiologies other than SCI.
3
Future studies are required to establish its potential efﬁcacy in combination with other analgesic drugs.

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