Brivaracetam for spinal cord injury-related neuropathic pain: results of a pilot double-blinded, randomized, placebo-controlled clinical trial.

OBJECTIVE

Assess feasibility, safety, and tolerability of 3 months of oral brivaracetam for severe (9-10/10) spinal cord injury-related neuropathic pain.

METHODS

We conducted a multisite pilot study where adults were randomized to 3 months of brivaracetam (100 mg BID) or placebo. Pain was assessed via the Brief Pain Inventory, the International Spinal Cord Injury Pain Basic Dataset (version 2.0), and a daily pain diary.

RESULTS

We enrolled 24 participants across 2 sites and 14 participants were included in the final analysis (n = 8 placebo, n = 6 brivaracetam). The drug was tolerated with expected, nonserious side effects (nausea if taken on an empty stomach, fatigue that improved after 2-3 days). Side effects were more common in the brivaracetam group (73%, n = 8 vs 33%, n = 3). We observed a mean 2.7-point reduction in daily worst pain in the brivaracetam group compared to a 1.0-point reduction in the placebo group. The percentage of participants experiencing 30% (100% vs 60%) and 50% (60% vs 12.5%) pain reduction was greater in the brivaracetam group.

CONCLUSIONS

These findings suggest safety, tolerability, and feasibility of brivaracetam for treating neuropathic pain in spinal cord injury. These pilot findings will be used to power future efficacy clinical trials.