The Effects of Lacosamide on Patients With Chronic Migraine: A Randomized, Double‐Blind, Clinical Trial

Purpose: Calcitonin gene‐related peptide (CGRP) is a key peptide released during trigeminal system‐initiated migraine attacks. Evidence suggests that lacosamide can inhibit CGRP release. This study aimed to assess the effectiveness of lacosamide in patients with chronic migraine. Methods: This double‐blind, randomized clinical study involved 83 chronic migraine patients, who were assigned to either a lacosamide group or a placebo group. The intervention group received 50 mg of lacosamide twice daily, with a weekly increase to a maximum tolerated dose of 200 mg twice daily, along with topiramate 25 mg twice daily. The placebo group received a placebo along with topiramate for 12 weeks. Headache frequency and severity were assessed using the NRS and VAS. Disability was evaluated with the MIDAS questionnaire at baseline and after 3 months. Results: Of the 83 patients enrolled in the study, 66 completed it and were analyzed. The intervention group exhibited a significant reduction in headache severity, as measured by VAS and headache frequency ( p : 0.001). Outdoor and indoor activity performance and headache‐free and analgesic‐free days significantly improved in the intervention group compared to the control group during the study period ( p : < 0.01). Most patients in the intervention group exhibited lower MIDAS disability scores, although the difference was not statistically significant between two groups ( p : 0.291). Conclusion: In conclusion, our findings suggest that lacosamide could be effective in reducing the frequency and severity of headaches in people with chronic migraines. Additionally, the tolerability of this treatment regimen for migraine prevention was satisfactory, with no significant side effects. Trial Registration: Iranian Registry of Clinical Trials: IRCT20190804044429N9