Pain reduction and tolerability of mirogabalin in trigeminal neuralgia: A prospective observational study
Hiroaki Matsumoto, Yasunori Yoshida, Akihiro Okada, Yusuke Tomogane, Atsushi Masuda, Ikuya Yamaura, Hiroaki Minami, Yasuhisa YoshidaAbstract
Objectives/Background
Our objective was to assess the short‐term treatment response and tolerability of mirogabalin in patients with trigeminal neuralgia. Trigeminal neuralgia is a debilitating neuropathic pain disorder for which carbamazepine is the first‐line therapy; however, this treatment is often limited by adverse effects. Mirogabalin, the third and most recently developed gabapentinoid, has demonstrated analgesic benefit with an acceptable safety profile in peripheral neuropathic pain conditions; however, its clinical role in trigeminal neuralgia remains unclear.
Methods
We conducted a prospective, open‐label, single‐arm observational pilot study at a single tertiary referral center in Japan between July 2021 and May 2025, enrolling 21 patients with trigeminal neuralgia, with pre‐ and postassessment of pain outcomes over a 3‐month follow‐up period. Pain intensity was assessed using the Numerical Rating Scale at baseline and at 1 and 3 months after treatment initiation. Responder rates and adverse events were also evaluated.
Results
The median Numerical Rating Scale score decreased from 6 (interquartile range [IQR], 6–8) at baseline to 2 (IQR, 2–4) at 1 month and 1 (IQR, 0–2) at 3 months (Friedman test, p < 0.001). At 1 month, 20 out of 21 patients (95%) achieved a ≥2‐point reduction, and all evaluable patients (20 out of 20) met this threshold at 3 months. Response rates for ≥70% improvement increased from 6 out of 21 (29%) at 1 month to 14 out of 20 (70%) at 3 months (McNemar test, p = 0.008). No patients discontinued treatment because of adverse events.
Conclusion
In this prospective, single‐arm pilot study, mirogabalin was associated with short‐term reductions in pain intensity and appeared to be generally well tolerated in patients with trigeminal neuralgia. These findings are hypothesis‐generating and require confirmation in larger, controlled, and longer‐term randomized trials to test the efficacy and safety of mirogabalin.