The novel third-generation calcium channel modulator crisugabalin appears to be safe and efficacious in the treatment of central neuropathic pain, as shown in a phase 3 trial.
After 12 weeks of treatment, the primary outcome of Average Daily Pain Score (ADPS) was significantly reduced for patients who received crisugabalin than for those who received placebo (mean, –2.39 vs –1.15; p<0.0001), reported Dr Xiaochong Fan from The First Affiliated Hospital of Zhengzhou University in Zhengzhou, China. [Fan X, et al, AAN 2026]
Results were similar in subgroups of patients who sustained a spinal cord injury (SCI; mean, –2.48 vs –1.20; p<0.0001) or stroke (mean, –2.32 vs –1.07; p<0.0001).
More crisugabalin-treated vs placebo-treated patients achieved a pain reduction of at least 30 percent (63.9 percent vs 33.2 percent; p<0.01) and at least 50 percent (36.1 percent vs 16.6 percent; p<0.01) in the overall population and in the SCI (≥30 percent: 65.7 percent vs 28.2 percent; ≥50 percent: 37.1 percent vs 11.7 percent) and stroke subgroups (≥30 percent: 62.1 percent vs 33.3 percent; ≥50 percent: 35 percent vs 21.6 percent).
Fan noted that the significant ADPS reduction with crisugabalin occurred as early as week 1, with sustained improvement throughout the 12-week treatment period in the overall population and the SCI and stroke subgroups.
Results for other secondary endpoints also favoured crisugabalin. Substantial improvements in sleep, mood, and quality of life occurred for crisugabalin-treated patients, both in the overall population and in the SCI and stroke subgroups.
In terms of safety, the rate of treatment-emergent adverse events (TEAEs) was 21.6 percent with crisugabalin and 16.6 percent with placebo. Dizziness, somnolence, and peripheral edema were the most common TEAEs.
According to Fan, most TEAEs were mild to moderate in severity, occurring early in the stage of medication and resolving spontaneously. There were no new safety signals documented.
“These results support crisugabalin as an effective and safe therapeutic option for patients with central neuropathic pain,” with statistically significant and clinically meaningful pain relief observed even in those with central post-stroke pain, which represent a particularly challenging population to treat, Fan said.
“With its titration-free regimen, rapid onset, robust efficacy, and favourable safety profile, crisugabalin may represent a potential new standard of care for these underserved patients,” he added.
The trial was conducted in China and included patients with symptoms related to central neuropathic pain, including SCI, post-stroke, Parkinson’s disease, and multiple sclerosis pain.
A total of 413 patients (average age 53 years, 67.3 percent male) were randomly assigned to receive crisugabalin 20–40 mg or placebo. Treatment was administered orally, twice a day for 12 weeks.
Crisugabalin is approved for the treatment of diabetic peripheral neuropathic pain in China.