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
Christine E. Lynn Rehabilitation Center, Department of Physical Medicine and Rehabilitation, University of Miami Miller School of Medicine, Miami, FL, USA.
Department of Rehabilitation Medicine, University of Minnesota Medical School, Minneapolis, MN, USA.
Pain Rep. 2025 Jun 16;10(4):e1301. doi: 10.1097/PR9.0000000000001301. eCollection 2025 Aug.
Assess feasibility, safety, and tolerability of 3 months of oral brivaracetam for severe (9-10/10) spinal cord injury-related neuropathic pain.
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.
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.
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.
评估口服布立西坦3个月治疗重度（9 - 10/10）脊髓损伤相关性神经病理性疼痛的可行性、安全性和耐受性。
我们开展了一项多中心试点研究，将成年人随机分为接受3个月布立西坦（100毫克，每日两次）治疗组或安慰剂组。通过简明疼痛量表、国际脊髓损伤疼痛基础数据集（2.0版）和每日疼痛日记对疼痛进行评估。
我们在2个地点招募了24名参与者，14名参与者纳入最终分析（n = 8安慰剂组，n = 6布立西坦组）。该药物耐受性良好，出现预期的非严重副作用（空腹服用时恶心，2 - 3天后疲劳感改善）。副作用在布立西坦组更常见（73%，n = 8 vs 33%，n = 3）。与安慰剂组每日最严重疼痛平均降低1.0分相比，布立西坦组平均降低2.7分。布立西坦组疼痛减轻30%（100% vs 60%）和50%（60% vs 12.5%）的参与者百分比更高。
这些发现表明布立西坦治疗脊髓损伤神经病理性疼痛具有安全性、耐受性和可行性。这些试点结果将用于为未来的疗效临床试验提供依据。
