Pain reports · 2025
Brivaracetam for spinal cord injury-related neuropathic pain: results of a pilot double-blinded, randomized, placebo-controlled clinical trial.
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Morse Leslie R, Battaglino Ricardo A, Nguyen Nguyen, DeVries Brian, Welch Abigail, Battaglino Ana Lucia, Linnman Clas, Stillman Michael, Wudlick Robert, Glossner Joda, Anderton Grant, Goldstein Richard, Falci Scott P
Аннотация
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.
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.