Design of phase 3 studies evaluating vixotrigine for treatment of trigeminal neuralgia
Journal of Pain Research Jul 05, 2020
Kotecha M, Cheshire WP, Finnigan H, et al. - In this research, the efficacy and safety of vixotrigine will investigate in treating pain experienced by patients with trigeminal neuralgia (TN) applying enriched enrollment randomized withdrawal trial designs. Two double-blind randomized withdrawal studies are designed to assess the effectiveness and safety of vixotrigine in comparison with placebo in participants with TN. Individuals criteria enroll ≥ 18 years old who have classical, purely paroxysmal TN diagnosed ≥ 3 months prior to study entry, who experience ≥ 3 paroxysms of pain/day. The two research will enroll a screening period, a 7-day run-in period, a 4- or 6-week single-dose-blind dose-optimization period (Study 1) or a 4-week open-label period (Study 2), and 14-week double-blind period. The vixotrigine 150 mg orally will prescribe three times daily to the individuals in the dose-optimization and open-label periods. There is a requirement for an effective, well-tolerated, non-invasive treatment for the neuropathic pain correlated with TN. The effectiveness and safety of vixotrigine will be assessed in treating pain experienced by patients with TN in these studies.
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